A Randomized Phase II Study Of CMF Alone And In Combination With Anti c-erbB2 Antibody (Herceptin) In Women With c-erbB2 Positive Metastatic Breast Cancer
Overview
- Phase
- Phase 2
- Intervention
- trastuzumab
- Conditions
- Breast Cancer
- Sponsor
- European Organisation for Research and Treatment of Cancer - EORTC
- Enrollment
- 90
- Locations
- 13
- Primary Endpoint
- Clinical heart failure rate measured by New York Heart Association classification, LVEF, and ECG
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
RATIONALE: Drugs used in chemotherapy such as cyclophosphamide, methotrexate, and fluorouracil use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy with trastuzumab may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining combination chemotherapy with trastuzumab in treating women who have metastatic breast cancer.
Detailed Description
OBJECTIVES: * Compare the incidence of clinical heart failure in women with c-erbB2-positive metastatic breast cancer treated with cyclophosphamide, methotrexate, and fluorouracil in combination with trastuzumab (Herceptin®). * Compare the therapeutic activity of this regimen, in terms of objective response rate, in these patients. * Compare the duration of response and time to progression in patients treated with this regimen. * Compare the toxic effects of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive CMF comprising cyclophosphamide orally on days 1-14 or IV on days 1 and 8 and methotrexate IV and fluorouracil IV on days 1 and 8. Patients also receive trastuzumab (Herceptin®) IV over 30-90 minutes once weekly beginning on day 1. Treatment repeats every 4 weeks for 8 courses. Patients then receive trastuzumab once every 3 weeks in the absence of disease progression, unacceptable toxicity, or patient refusal. Patients are followed every 8 weeks until documentation of disease progression or initiation of a new anticancer therapy. Patients developing disease progression are followed every 12 weeks. PROJECTED ACCRUAL: A total of 66 patients will be accrued for this study within 2 years.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
CMF + Herceptin
Intervention: trastuzumab
CMF + Herceptin
Intervention: CMF regimen
CMF + Herceptin
Intervention: cyclophosphamide
CMF + Herceptin
Intervention: fluorouracil
CMF + Herceptin
Intervention: methotrexate
Outcomes
Primary Outcomes
Clinical heart failure rate measured by New York Heart Association classification, LVEF, and ECG
Time Frame: from registration
Response rate by RECIST
Time Frame: from registration
Secondary Outcomes
- Duration of response by RECIST(from registration)
- Time to progression(from registration)
- Toxicity measured by CTC v2.0(from registration)