Clinical trial · Observational

A Survey Of Clinical Practice Of Adjuvant Treatment Of Breast Cancer Using Exemestane (Aromasin®) In Postmenopausal Hr+ Patients

NCT01305239CI-TRIAL-00006689ETAPEterminatedResults postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Why stopped (as posted): See termination reason in detailed description.

Summary

Brief summary (as posted)

Observational survey aiming to evaluate the tolerability of Aromasin and the ways in which it is used in clinical practice in France (as adjuvant endocrine therapy).

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 (1)

Intervention	Type	Mapped drug	Match
Aromasin	Drug	Exemestane	ALIAS

Design

Arms and outcomes

Arms (1)

label
Postmenopausal ER+ patients treated by Aromasin.
interventionNames
1. Drug: Aromasin

Primary outcomes (1)

measure
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame
Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed
description
Any untoward medical occurrence in a patient who received study drug was considered an adverse event without regard to possibility of causal relationship. An adverse event resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a serious adverse event: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

Secondary outcomes (4)

measure
Reasons for Discontinuation of Aromasin Therapy
timeFrame

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 45 Years

Show eligibility criteria text

Inclusion Criteria:

Postmenopausal patients, defined as: natural menopause for at least 1 year, surgical ovariectomy, chemotherapy-induced amenorrhoea for at least 2 years.

Patients who have had surgical treatment for histologically confirmed breast cancer that was nonmetastatic at the time of the initial diagnosis.

Patients whose tumour was hormone receptor positive (HR+, ER+ and/or PR+). Patients initiated on Aromasin at least 2 months before inclusion but not more than 1 year.

Exclusion Criteria:

Patients for whom Aromasin treatment is contraindicated. Presence of metastasis or a contralateral tumour. Another adjuvant endocrine therapy. Another concomitant antineoplastic treatment (except for Herceptin®). Participation in a clinical trial with an investigational drug during the 30 days prior to enrolment in the study.

References

Publications (0)

Data not yet available

No reference posted for this study.