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| Sponsor: | European Organization for Research and Treatment of Cancer |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00036868 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Biological: trastuzumab Drug: CMF regimen Drug: cyclophosphamide Drug: fluorouracil Drug: methotrexate |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label |
| 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 |
| Study Start Date: | February 2002 |
OBJECTIVES:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
At least 1 unidimensionally measurable target lesion
No CNS metastases
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
For patients age 18 to 69:
For patients age 70 and over:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| Belgium | |
| Institut Jules Bordet | |
| Brussels, Belgium, 1000 | |
| Universitair Ziekenhuis Antwerpen | |
| Edegem, Belgium, B-2650 | |
| Ziekenhuis Netwerk Antwerpen Middelheim | |
| Antwerp, Belgium, 2020 | |
| Denmark | |
| Herlev Hospital - University Hospital of Copenhagen | |
| Copenhagen, Denmark, DK-2730 | |
| Egypt | |
| National Cancer Institute of Egypt | |
| Cairo, Egypt | |
| France | |
| Centre de Lutte Contre le Cancer Georges-Francois Leclerc | |
| Dijon, France, 21079 | |
| Netherlands | |
| Leiden University Medical Center | |
| Leiden, Netherlands, 2300 CA | |
| Nijmegen Cancer Center at Radboud University Medical Center | |
| Nijmegen, Netherlands, NL-6500 HB | |
| Onze Lieve Vrouwe Gasthuis | |
| Amsterdam, Netherlands, 1091 HA | |
| Poland | |
| Medical University of Gdansk | |
| Gdansk, Poland, 80-211 | |
| Serbia | |
| Institute of Oncology and Radiology of Serbia | |
| Belgrade, Serbia, 11000 | |
| South Africa | |
| Medical Oncology Centre of Rosebank | |
| Johannesburg, South Africa, 2193 | |
| United Kingdom, Scotland | |
| Western Infirmary | |
| Glasgow, Scotland, United Kingdom, G11 6NT | |
| Investigator: | Martine J. Piccart-Gebhart, MD, PhD | Institut Jules Bordet |
| Investigator: | Pierre Fumoleau, MD, PhD | Centre de Lutte Contre le Cancer Georges-Francois Leclerc |
| Investigator: | Laura Biganzoli, MD | Institut Jules Bordet |
More Information
| Study ID Numbers: | CDR0000069332, EORTC-10995, EORTC-16999, IDBBC-EORTC-10995 |
| Study First Received: | May 13, 2002 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00036868 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV breast cancer recurrent breast cancer |
|
Antimetabolites Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Cyclophosphamide Reproductive Control Agents Neoplasms by Site Therapeutic Uses Abortifacient Agents Trastuzumab Methotrexate Dermatologic Agents Alkylating Agents |
Nucleic Acid Synthesis Inhibitors Breast Diseases Skin Diseases Breast Neoplasms Enzyme Inhibitors Folic Acid Antagonists Abortifacient Agents, Nonsteroidal Immunosuppressive Agents Pharmacologic Actions Neoplasms Fluorouracil Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents |