Clinical trial · Interventional

Weekly Gemcitabine and Trastuzumab in the Treatment of Patients With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Metastatic Breast Cancer

Phase II Trial of Weekly Gemcitabine and Herceptin in the Treatment of Patients With HER-2 Overexpressing Metastatic Breast Cancer

NCT00193063CI-TRIAL-00014006completedPhase 2Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

Due to its remarkable activity as salvage treatment in women with metastatic breast cancer as well as the additive activity observed for gemcitabine administered in combination with trastuzumab, the clinical activity of the combination of gemcitabine administered with trastuzumab represents an exciting and ideal combination to further evaluate in Her 2 over-expressing metastatic breast cancer patients.

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 (2)

Intervention	Type	Mapped drug	Match
Gemcitabine	Drug	Gemcitabine	ALIAS
Trastuzumab	Drug	Trastuzumab	ALIAS

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Intervention
description
All patients entering this trial received treatment with a combination of gemcitabine and trastuzumab. Gemcitabine 1000 mg/m2 was administered intravenously on days 1, 8,and 15 of a 28-day cycle. Trastuzumab was administered as a 4 mg/kg intravenous loading dose on day 1 and subsequently at a dose of 2 mg/kg on a weekly basis.
interventionNames
1. Drug: Trastuzumab
2. Drug: Gemcitabine

Primary outcomes (1)

measure
Overall Response Rate (ORR)
timeFrame
18 Months
description
The Percentage of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Secondary outcomes (2)

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

To be included in this study, you must meet the following criteria:

* Her-2 positive metastatic breast cancer confirmed by biopsy
* Measurable disease
* Able to perform activities of daily living without considerable
* No previous chemotherapy with gemcitabine
* No more than one prior chemotherapy regimen for metastatic breast cancer
* Adequate bone marrow, liver and renal function
* Normal heart function
* Give written informed consent prior to entering this study.

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

* Received previous treatment with gemcitabine
* History of brain metastases
* Serious underlying medical conditions

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

References

Publications (1)

RESULTYardley DA, Burris HA 3rd, Hanson S, Greco FA, Spigel DR, Barton J, Hainsworth JD. Weekly gemcitabine and trastuzumab in the treatment of patients with HER2-overexpressing metastatic breast cancer. Clin Breast Cancer. 2009 Aug;9(3):178-83. doi: 10.3816/CBC.2009.n.029. PMID 19661042