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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Ziekenhuis Netwerk Antwerpen Middelheim
Antwerp, Belgium
Institut Jules Bordet
Brussels, Belgium
Universitair Ziekenhuis Antwerpen
Edegem, Belgium
Herlev Hospital - University Hospital of Copenhagen
Copenhagen, Denmark
National Cancer Institute of Egypt
Cairo, Egypt
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
Dijon, France
Onze Lieve Vrouwe Gasthuis
Amsterdam, Netherlands
Leiden University Medical Center
Leiden, Netherlands
Nijmegen Cancer Center at Radboud University Medical Center
Nijmegen, Netherlands
Medical University of Gdansk
Gdansk, Poland
...and 3 more locations
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
Duration of response by RECIST
Time frame: from registration
Time to progression
Time frame: from registration
Toxicity measured by CTC v2.0
Time frame: from registration
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