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
- 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
- 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
PROJECTED ACCRUAL: A total of 66 patients will be accrued for this study within 2 years.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Clinical heart failure rate measured by New York Heart Association classification, LVEF, and ECG
Western General Hospital, Edinburgh
United States: Federal Government