Combination Chemotherapy With Trastuzumab in Treating Women With Metastatic Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Registration Number
- NCT00036868
- Lead Sponsor
- European Organisation for Research and Treatment of Cancer - EORTC
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 90
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CMF + Herceptin trastuzumab - CMF + Herceptin CMF regimen - CMF + Herceptin fluorouracil - CMF + Herceptin methotrexate - CMF + Herceptin cyclophosphamide -
- Primary Outcome Measures
Name Time Method Clinical heart failure rate measured by New York Heart Association classification, LVEF, and ECG from registration Response rate by RECIST from registration
- Secondary Outcome Measures
Name Time Method Duration of response by RECIST from registration Time to progression from registration Toxicity measured by CTC v2.0 from registration
Trial Locations
- Locations (13)
Institute of Oncology and Radiology of Serbia
🇷🇸Belgrade, Serbia
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
🇫🇷Dijon, France
National Cancer Institute of Egypt
🇪🇬Cairo, Egypt
Leiden University Medical Center
🇳🇱Leiden, Netherlands
Medical University of Gdansk
🇵🇱Gdansk, Poland
Onze Lieve Vrouwe Gasthuis
🇳🇱Amsterdam, Netherlands
Nijmegen Cancer Center at Radboud University Medical Center
🇳🇱Nijmegen, Netherlands
Ziekenhuis Netwerk Antwerpen Middelheim
🇧🇪Antwerp, Belgium
Institut Jules Bordet
🇧🇪Brussels, Belgium
Universitair Ziekenhuis Antwerpen
🇧🇪Edegem, Belgium
Herlev Hospital - University Hospital of Copenhagen
🇩🇰Copenhagen, Denmark
Medical Oncology Centre of Rosebank
🇿🇦Johannesburg, South Africa
Western Infirmary
🇬🇧Glasgow, Scotland, United Kingdom