Combination Chemotherapy With Trastuzumab in Treating Women With Metastatic Breast Cancer
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.
Drug: CMF regimen
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Clinical heart failure rate measured by New York Heart Association classification, LVEF, and ECG [ Time Frame: from registration ] [ Designated as safety issue: No ]
- Response rate by RECIST [ Time Frame: from registration ] [ Designated as safety issue: No ]
- Duration of response by RECIST [ Time Frame: from registration ] [ Designated as safety issue: No ]
- Time to progression [ Time Frame: from registration ] [ Designated as safety issue: No ]
- Toxicity measured by CTC v2.0 [ Time Frame: from registration ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2002|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
|Experimental: CMF + Herceptin||Biological: trastuzumab Drug: CMF regimen Drug: cyclophosphamide Drug: fluorouracil Drug: methotrexate|
- 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.
|Ziekenhuis Netwerk Antwerpen Middelheim|
|Antwerp, Belgium, 2020|
|Institut Jules Bordet|
|Brussels, Belgium, 1000|
|Universitair Ziekenhuis Antwerpen|
|Edegem, Belgium, B-2650|
|Herlev Hospital - University Hospital of Copenhagen|
|Copenhagen, Denmark, DK-2730|
|National Cancer Institute of Egypt|
|Centre de Lutte Contre le Cancer Georges-Francois Leclerc|
|Dijon, France, 21079|
|Onze Lieve Vrouwe Gasthuis|
|Amsterdam, Netherlands, 1091 HA|
|Leiden University Medical Center|
|Leiden, Netherlands, 2300 CA|
|Nijmegen Cancer Center at Radboud University Medical Center|
|Nijmegen, Netherlands, NL-6500 HB|
|Medical University of Gdansk|
|Gdansk, Poland, 80-211|
|Institute of Oncology and Radiology of Serbia|
|Belgrade, Serbia, 11000|
|Medical Oncology Centre of Rosebank|
|Johannesburg, South Africa, 2193|
|Glasgow, Scotland, United Kingdom, G11 6NT|
|Study Chair:||David Cameron||Western General Hospital, Edinburgh|