NCT01094184 — A Study of Bevacizumab With Taxane Therapy in Participants With Triple Negative Breast Cancer · CancerIndex

Clinical trial · Interventional

A Study of Bevacizumab With Taxane Therapy in Participants With Triple Negative Breast Cancer

Open-Label Study of Bevacizumab (Avastin®) and Taxane Monotherapy for the First-Line Treatment of Patients With Advanced Triple Negative Breast Cancer

NCT01094184CI-TRIAL-00032206BATMANcompletedPhase 4Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

This open-label, multi-center study will evaluate the safety, tolerability and effect of bevacizumab (Avastin) in combination with taxane (paclitaxel/ docetaxel) monotherapy on disease progression, survival time and Karnofsky performance status in female participants with estrogen-, progesterone- and human epidermal growth factor receptor 2 (HER2)-negative (triple-negative) breast cancer.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Breast Cancer	Malignant Breast Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (3)

Intervention	Type	Mapped drug	Match
Bevacizumab	Drug	Bevacizumab	ALIAS
Docetaxel	Drug	Docetaxel	ALIAS
Paclitaxel	Drug	Paclitaxel	ALIAS

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
Bevacizumab 10 mg/kg Q2W
description
Participants will receive bevacizumab at a dose of 10 milligrams per kilogram (mg/kg) every 2 weeks (Q2W) as intravenous infusion along with paclitaxel every week (Q1W) or docetaxel every 3 weeks (Q3W) as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
interventionNames
1. Drug: Bevacizumab
2. Drug: Paclitaxel
3. Drug: Docetaxel
type
EXPERIMENTAL
label
Bevacizumab 15 mg/kg Q3W
description
Participants will receive bevacizumab at a dose of 15 mg/kg Q3W as intravenous infusion along with paclitaxel Q1W or docetaxel Q3W as per discretion of the treating physician until disease progression, unacceptable toxicity or withdrawal of consent.
interventionNames
1. Drug: Bevacizumab
2. Drug: Paclitaxel
3. Drug: Docetaxel

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

* Histologically confirmed triple-negative (estrogen, progesterone, and HER-2 receptor negative) adenocarcinoma of the breast in pre- or post-menopausal women with measurable or non-measurable metastatic disease
* Participant who in the Investigator's opinion requires combination therapy for their disease
* Life expectancy of greater than or equal to (\>/=)12 weeks

Exclusion Criteria:

* Previous chemotherapy for metastatic breast cancer
* Participants currently undergoing radiation therapy for the treatment of metastatic disease (apart from the relief of metastatic bone pain)
* Major surgery or significant traumatic injury within 28 days prior to enrollment or anticipation of the need for major surgery during study treatment

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Mar 1, 2010
Primary completion: Dec 1, 2015
Completion: Dec 1, 2015
First posted: Mar 26, 2010
Last update posted: Mar 22, 2018
Results first posted: Mar 22, 2018
Enrollment: 49 (actual)
Lead sponsor: Hoffmann-La Roche INDUSTRY

Data updated 22 days agoSource updated Mar 22, 2018source: clinicaltrials

Locations

Locations by country (10)

Country	Sites	Recruiting
United Kingdom	10	0

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.

measure
Change From Baseline in Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) Score at Cycle 2
timeFrame
Baseline, Cycle 2 (Cycle length=2 and 3 weeks)
description
FACT-B is used for assessment of health-related quality of life (QoL) in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
measure
Change From Baseline in FACT-B Score at Cycle 3
timeFrame
Baseline, Cycle 3 (Cycle length=2 and 3 weeks)
description
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
measure
Change From Baseline in FACT-B Score at Cycle 4
timeFrame
Baseline, Cycle 4 (Cycle length=2 and 3 weeks)
description
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
measure
Change From Baseline in FACT-B Score at Cycle 5
timeFrame
Baseline, Cycle 5 (Cycle length=2 and 3 weeks)
description
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
measure
Change From Baseline in FACT-B Score at Cycle 6
timeFrame
Baseline, Cycle 6 (Cycle length=2 and 3 weeks)
description
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
measure
Change From Baseline in FACT-B Score at Cycle 7
timeFrame
Baseline, Cycle 7 (Cycle length=2 and 3 weeks)
description
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
measure
Change From Baseline in FACT-B Score at Cycle 8
timeFrame
Baseline, Cycle 8 (Cycle length=2 and 3 weeks)
description
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
measure
Change From Baseline in FACT-B Score At Cycle 9
timeFrame
Baseline, Cycle 9 (Cycle length=2 and 3 weeks)
description
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
measure
Change From Baseline in FACT-B Score at Cycle 10
timeFrame
Baseline, Cycle 10 (Cycle length=2 and 3 weeks)
description
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
measure
Change From Baseline in FACT-B Score at Cycle 11
timeFrame
Baseline, Cycle 11 (Cycle length=2 and 3 weeks)
description
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
measure
Change From Baseline in FACT-B Score at Cycle 12
timeFrame
Baseline, Cycle 12 (Cycle length=2 and 3 weeks)
description
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
measure
Change From Baseline in FACT-B Score at Cycle 13
timeFrame
Baseline, Cycle 13 (Cycle length=2 and 3 weeks)
description
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
measure
Change From Baseline in FACT-B Score at Cycle 14
timeFrame
Baseline, Cycle 14 (Cycle length=2 and 3 weeks)
description
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
measure
Change From Baseline in FACT-B Score at Cycle 15
timeFrame
Baseline, Cycle 15 (Cycle length=2 and 3 weeks)
description
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
measure
Change From Baseline in FACT-B Score at Cycle 16
timeFrame
Baseline, Cycle 16 (Cycle length=2 and 3 weeks)
description
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
measure
Change From Baseline in FACT-B Score at Cycle 17
timeFrame
Baseline, Cycle 17 (Cycle length=2 and 3 weeks)
description
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
measure
Change From Baseline in FACT-B Score at Cycle 18
timeFrame
Baseline, Cycle 18 (Cycle length=2 and 3 weeks)
description
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
measure
Change From Baseline in FACT-B Score at Cycle 20
timeFrame
Baseline, Cycle 20 (Cycle length=2 and 3 weeks)
description
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
measure
Change From Baseline in FACT-B Score at Cycle 21
timeFrame
Baseline, Cycle 21 (Cycle length=2 and 3 weeks)
description
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
measure
Change From Baseline in FACT-B Score at Cycle 22
timeFrame
Baseline, Cycle 22 (Cycle length=2 and 3 weeks)
description
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
measure
Change From Baseline in FACT-B Score at Cycle 23
timeFrame
Baseline, Cycle 23 (Cycle length=2 and 3 weeks)
description
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
measure
Change From Baseline in FACT-B Score at Cycle 24
timeFrame
Baseline, Cycle 24 (Cycle length=2 and 3 weeks)
description
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
measure
Change From Baseline in FACT-B Score at Cycle 25
timeFrame
Baseline, Cycle 25 (Cycle length=2 and 3 weeks)
description
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
measure
Change From Baseline in FACT-B Score at Cycle 26
timeFrame
Baseline, Cycle 26 (Cycle length=2 and 3 weeks)
description
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
measure
Change From Baseline in FACT-B Score at Cycle 27
timeFrame
Baseline, Cycle 27 (Cycle length=2 and 3 weeks)
description
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
measure
Change From Baseline in FACT-B Score at Cycle 28
timeFrame
Baseline, Cycle 28 (Cycle length=2 and 3 weeks)
description
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
measure
Change From Baseline in FACT-B Score at Cycle 29
timeFrame
Baseline, Cycle 29 (Cycle length=2 and 3 weeks)
description
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
measure
Change From Baseline in FACT-B Score at Cycle 30
timeFrame
Baseline, Cycle 30 (Cycle length=2 and 3 weeks)
description
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
measure
Change From Baseline in FACT-B Score at Cycle 32
timeFrame
Baseline, Cycle 32 (Cycle length=2 and 3 weeks)
description
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
measure
Change From Baseline in FACT-B Score at Cycle 36
timeFrame
Baseline, Cycle 36 (Cycle length=2 and 3 weeks)
description
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
measure
Change From Baseline in FACT-B Score at Cycle 37
timeFrame
Baseline, Cycle 37 (Cycle length=2 and 3 weeks)
description
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
measure
Change From Baseline in FACT-B Score at Cycle 39
timeFrame
Baseline, Cycle 39 (Cycle length=2 and 3 weeks)
description
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
measure
Change From Baseline in FACT-B Score at Cycle 42
timeFrame
Baseline, Cycle 42 (Cycle length=2 and 3 weeks)
description
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
measure
Change From Baseline in FACT-B Score at Cycle 44
timeFrame
Baseline, Cycle 44 (Cycle length=2 and 3 weeks)
description
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
measure
Change From Baseline in FACT-B Score at Cycle 46
timeFrame
Baseline, Cycle 46 (Cycle length=2 and 3 weeks)
description
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
measure
Change From Baseline in FACT-B Score at End of Study
timeFrame
Baseline, end of study (4-6 weeks after the last bevacizumab infusion) (maximum up to 5 years and 9 months)
description
FACT-B is used for assessment of health-related QoL in participants with breast cancer. It consists of 36 items, summarized to 5 subscales: physical (7 items), functional (7 items), social/family (7 items); all 3 ranged from 0 to 28, emotional (6 items) ranging from 0 to 24, and breast cancer subscale (9 items) ranging from 0 to 36; high subscale score represents a better QoL. All single-item measures range from 0='Not at all' to 4='Very much'. Total possible score ranged from 0 to 144. High scale score represents a better QoL.
measure
Change From Baseline in Euro Quality of Life (EQ-5D) - Health State Questionnaire Score at Cycle 2
timeFrame
Baseline, Cycle 2 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
measure
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 3
timeFrame
Baseline, Cycle 3 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
measure
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 4
timeFrame
Baseline, Cycle 4 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
measure
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 5
timeFrame
Baseline, Cycle 5 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
measure
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 6
timeFrame
Baseline, Cycle 6 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
measure
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 7
timeFrame
Baseline, Cycle 7 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
measure
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 8
timeFrame
Baseline, Cycle 8 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
measure
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 9
timeFrame
Baseline, Cycle 9 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
measure
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 10
timeFrame
Baseline, Cycle 10 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
measure
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 11
timeFrame
Baseline, Cycle 11 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
measure
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 12
timeFrame
Baseline, Cycle 12 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
measure
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 13
timeFrame
Baseline, Cycle 13 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
measure
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 14
timeFrame
Baseline, Cycle 14 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
measure
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 15
timeFrame
Baseline, Cycle 15 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
measure
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 16
timeFrame
Baseline, Cycle 16 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
measure
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 17
timeFrame
Baseline, Cycle 17 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
measure
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 18
timeFrame
Baseline, Cycle 18 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
measure
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 20
timeFrame
Baseline, Cycle 20 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
measure
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 21
timeFrame
Baseline, Cycle 21 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
measure
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 22
timeFrame
Baseline, Cycle 22 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
measure
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 23
timeFrame
Baseline, Cycle 23 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
measure
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 24
timeFrame
Baseline, Cycle 24 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
measure
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 25
timeFrame
Baseline, Cycle 25 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
measure
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 26
timeFrame
Baseline, Cycle 26 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
measure
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 27
timeFrame
Baseline, Cycle 27 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
measure
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 28
timeFrame
Baseline, Cycle 28 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
measure
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 29
timeFrame
Baseline, Cycle 29 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
measure
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 30
timeFrame
Baseline, Cycle 30 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
measure
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 32
timeFrame
Baseline, Cycle 32 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
measure
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 36
timeFrame
Baseline, Cycle 36 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
measure
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 37
timeFrame
Baseline, Cycle 37 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
measure
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 39
timeFrame
Baseline, Cycle 39 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
measure
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 40
timeFrame
Baseline, Cycle 40 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
measure
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 42
timeFrame
Baseline, Cycle 42 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
measure
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 44
timeFrame
Baseline, Cycle 44 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
measure
Change From Baseline in EQ-5D- Health State Questionnaire Score at Cycle 46
timeFrame
Baseline, Cycle 46 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
measure
Change From Baseline in EQ-5D- Health State Questionnaire Score at End of Study
timeFrame
Baseline, end of study (4-6 weeks after the last bevacizumab infusion) (maximum up to 5 years and 9 months)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state. Scoring formula developed by EuroQol Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state.
measure
Change From Baseline in EQ-5D - Visual Analogue Scale (VAS) Score at Cycle 2
timeFrame
Baseline, Cycle 2 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
measure
Change From Baseline in EQ-5D-VAS Score at Cycle 3
timeFrame
Baseline, Cycle 3 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
measure
Change From Baseline in EQ-5D-VAS Score at Cycle 4
timeFrame
Baseline, Cycle 4 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
measure
Change From Baseline in EQ-5D-VAS Score at Cycle 5
timeFrame
Baseline, Cycle 5 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
measure
Change From Baseline in EQ-5D-VAS Score at Cycle 6
timeFrame
Baseline, Cycle 6 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
measure
Change From Baseline in EQ-5D-VAS Score at Cycle 7
timeFrame
Baseline, Cycle 7 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
measure
Change From Baseline in EQ-5D-VAS Score at Cycle 8
timeFrame
Baseline, Cycle 8 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
measure
Change From Baseline in EQ-5D-VAS Score at Cycle 9
timeFrame
Baseline, Cycle 9 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
measure
Change From Baseline in EQ-5D-VAS Score at Cycle 10
timeFrame
Baseline, Cycle 10 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
measure
Change From Baseline in EQ-5D-VAS Score at Cycle 11
timeFrame
Baseline, Cycle 11 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
measure
Change From Baseline in EQ-5D-VAS Score at Cycle 12
timeFrame
Baseline, Cycle 12 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
measure
Change From Baseline in EQ-5D-VAS Score at Cycle 13
timeFrame
Baseline, Cycle 13 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
measure
Change From Baseline in EQ-5D-VAS Score at Cycle 14
timeFrame
Baseline, Cycle 14 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
measure
Change From Baseline in EQ-5D-VAS Score at Cycle 15
timeFrame
Baseline, Cycle 15 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
measure
Change From Baseline in EQ-5D-VAS Score at Cycle 16
timeFrame
Baseline, Cycle 16 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
measure
Change From Baseline in EQ-5D-VAS Score at Cycle 17
timeFrame
Baseline, Cycle 17 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
measure
Change From Baseline in EQ-5D-VAS Score at Cycle 18
timeFrame
Baseline, Cycle 18 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
measure
Change From Baseline in EQ-5D-VAS Score at Cycle 20
timeFrame
Baseline, Cycle 20 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
measure
Change From Baseline in EQ-5D-VAS Score at Cycle 21
timeFrame
Baseline, Cycle 21 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
measure
Change From Baseline in EQ-5D-VAS Score at Cycle 22
timeFrame
Baseline, Cycle 22 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
measure
Change From Baseline in EQ-5D-VAS Score at Cycle 23
timeFrame
Baseline, Cycle 23 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
measure
Change From Baseline in EQ-5D-VAS Score at Cycle 24
timeFrame
Baseline, Cycle 24 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
measure
Change From Baseline in EQ-5D-VAS Score at Cycle 25
timeFrame
Baseline, Cycle 25 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
measure
Change From Baseline in EQ-5D-VAS Score at Cycle 26
timeFrame
Baseline, Cycle 26 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
measure
Change From Baseline in EQ-5D-VAS Score at Cycle 27
timeFrame
Baseline, Cycle 27 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
measure
Change From Baseline in EQ-5D-VAS Score at Cycle 28
timeFrame
Baseline, Cycle 28 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
measure
Change From Baseline in EQ-5D-VAS Score at Cycle 29
timeFrame
Baseline, Cycle 29 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
measure
Change From Baseline in EQ-5D-VAS Score at Cycle 30
timeFrame
Baseline, Cycle 30 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
measure
Change From Baseline in EQ-5D-VAS Score at Cycle 32
timeFrame
Baseline, Cycle 32 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
measure
Change From Baseline in EQ-5D-VAS Score at Cycle 36
timeFrame
Baseline, Cycle 36 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
measure
Change From Baseline in EQ-5D-VAS Score at Cycle 37
timeFrame
Baseline, Cycle 37 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
measure
Change From Baseline in EQ-5D-VAS Score at Cycle 39
timeFrame
Baseline, Cycle 39 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
measure
Change From Baseline in EQ-5D-VAS Score at Cycle 40
timeFrame
Baseline, Cycle 40 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
measure
Change From Baseline in EQ-5D-VAS Score at Cycle 42
timeFrame
Baseline, Cycle 42 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
measure
Change From Baseline in EQ-5D-VAS Score at Cycle 44
timeFrame
Baseline, Cycle 44 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
measure
Change From Baseline in EQ-5D-VAS Score at Cycle 46
timeFrame
Baseline, Cycle 46 (Cycle length=2 and 3 weeks)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.
measure
Change From Baseline in EQ-5D-VAS Score at End of Study
timeFrame
Baseline, end of study (4-6 weeks after the last bevacizumab infusion) (maximum up to 5 years and 9 months)
description
EQ-5D: participant rated questionnaire to assess health-related QoL in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state.

Secondary outcomes (5)

measure
Percentage of Participants Who Died Due to Any Cause
timeFrame
Baseline up to death (overall approximately 5 years and 9 months)
measure
Overall Survival
timeFrame
Baseline up to death (overall approximately 5 years and 9 months)
description
Overall survival was defined as the time from start of taxane plus bevacizumab therapy to death due to any cause. Overall survival was calculated in months as (date of death from any cause - date of first administration of taxane or bevacizumab + 1) / 30.4375 and rounded to 1 decimal place. Participants for whom no death was captured on the clinical database were censored at the last date they were known to be alive.
measure
Percentage of Participants With Disease Progression
timeFrame
Baseline up to disease progression (overall approximately 5 years and 9 months)
description
Disease progression was defined as greater than or equal to (\>/=) 20 percent (%) relative increase and \>/=5 mm of absolute increase in the sum of diameters (SD) of target lesions (TLs), taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.
measure
Time to Disease Progression
timeFrame
Baseline up to disease progression (overall approximately 5 years and 9 months)
description
Time to disease progression was defined as the time from the start of taxane plus bevacizumab therapy to investigator assessed disease progression and was calculated in months as (date of Investigator assessed disease progression - date of first administration of taxane or bevacizumab + 1) / 30.4375 and rounded to 1 decimal place. Participants who had not progressed at the time of study completion (including participants who had died before progressive disease) or who were lost to follow-up were censored at the last bevacizumab administration date. Disease progression was defined as \>/=20% relative increase and \>/=5 mm of absolute increase in the SD of TLs, taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.
measure
Percentage of Participants By Karnofsky Performance Status Scale Scores
timeFrame
Baseline, Cycle 1 thereafter every cycle up to Cycle 47 (Cycle length=2 and 3 weeks), end of study (4-6 weeks after the last bevacizumab infusion) (maximum up to 5 years and 9 months)
description
Karnofsky performance score is used to quantify participant's general well-being and activities of daily life and participants are classified based on their functional impairment. Karnofsky performance score is 11 level score which range between 0% (death) to 100% (no evidence of disease). Higher score means higher ability to perform daily tasks.