Status:
COMPLETED
Trastuzumab in Combination With Vinorelbine or Taxane-Based Chemotherapy in Patients With Metastatic Breast Cancer
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Massachusetts General Hospital
Brigham and Women's Hospital
Conditions:
Breast Cancer
Stage IV Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare two different combinations of chemotherapy with trastuzumab as initial treatment for HER2 positive advanced breast cancer. Half of the patients will receive tra...
Detailed Description
* All patients will receive trastuzumab then be randomized into one of two arms. Arm A: Trastuzumab in combination with weekly vinorelbine and Arm B: Trastuzumab in combination with a weekly taxane-ba...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed invasive breast cancer, with stage IV disease
- Tumors must be HER2 overexpressing
- Measurable disease, defined as a least one lesion that can be accurately measured in at least one dimension
- 18 years of age or older
- Life expectancy of greater than 6 months
- ECOG performance status of 0-2
- ANC count \> 1,500/mm3
- Platelets \> 100,000/mm3
- Total bilirubin \< 1.5 mg/dl
- AST/ALT \< 115 U/I
- Creatinine \< 2.0 mg/dl
- Glucose \< 200 mg/dl
- LVEF \> 50%
Exclusion
- Prior chemotherapy or prior trastuzumab therapy for metastatic breast cancer
- Concurrent hormonal therapy, chemotherapy, or radiation treatments
- Pregnant or lactating women
- Known brain metastases or leptomeningeal carcinomatosis
- History of grade 3 or 4 allergic reactions attributed to compounds of similar chemical or biologic composition to the agents in this study
- Pre-existing neuropathy from any cause in excess of grade 1
- Uncontrolled intercurrent illness
- History of other non-breast cancer malignancy except for carcinoma in situ of the cervix or non-melanoma skin cancer
- Patients taking macrolide antibiotics, ketoconazole, or AZT
Key Trial Info
Start Date :
August 1 2001
Trial Type :
INTERVENTIONAL
End Date :
December 1 2007
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT00146549
Start Date
August 1 2001
End Date
December 1 2007
Last Update
November 2 2009
Active Locations (2)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115