This trial is active, not recruiting.

Condition breast cancer
Treatments trastuzumab, cmf regimen, cyclophosphamide, fluorouracil, methotrexate
Phase phase 2
Target HER2
Sponsor European Organisation for Research and Treatment of Cancer - EORTC
Start date February 2002
End date June 2009
Trial size 90 participants
Trial identifier NCT00036868, EORTC-10995, EORTC-10995-16999, EORTC-16999, IDBBC-EORTC-10995


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
cmf regimen

Primary Outcomes

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

Secondary Outcomes

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

Eligibility Criteria

Female participants at least 18 years old.

DISEASE CHARACTERISTICS: - Histologically confirmed metastatic breast cancer c-erbB2 positive (3+ overexpression by the HercepTest™ method) in the primary tumor or metastatic site - At least 1 unidimensionally measurable target lesion - At least 20 mm by conventional techniques OR - At least 10 mm by spiral CT scan - Lesions that have been irradiated in the preceding 3 months cannot be used as target lesions unless they have appeared or clearly progressed since prior irradiation - No bone lesions as the only target lesions - No contralateral breast cancer that is c-erbB2-positive or c-erbB2-negative/unknown, with status determined on a metastatic site - No CNS metastases - CT scan of brain and CSF cytology are required if neurologic symptoms are present - Hormone receptor status: - Any estrogen or progesterone receptor status PATIENT CHARACTERISTICS: Age: - 18 and over Sex: - Female Menopausal status: - Any status Performance status: - ECOG 0-2 Life expectancy: - Not specified Hematopoietic: - Neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.25 times upper limit of normal (ULN) - Transaminases less than 2.5 times ULN (5 times ULN if liver metastases present) Renal: - For patients age 18 to 69: - Creatinine no greater than ULN - For patients age 70 and over: - Creatinine clearance normal Cardiovascular: - LVEF normal by MUGA or echocardiogram - No clinical heart failure Pulmonary: - No malignancy-associated dyspnea at rest - No requirement for supportive oxygen therapy Other: - Not pregnant or nursing - No other prior or concurrent malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or basal cell skin cancer - No psychological, familial, sociological, or geographical condition that would preclude compliance with study therapy and follow-up schedule PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior anti-c-erbB2 antibody, including trastuzumab (Herceptin®) - No other concurrent biologic therapy Chemotherapy: - No more than 1 prior chemotherapy regimen for metastatic breast cancer - Prior combination of cyclophosphamide, methotrexate, and fluorouracil (CMF) allowed in the adjuvant or metastatic setting only if the disease-free interval after completion of CMF was at least 12 months - Prior anthracyclines and/or taxanes allowed - At least 4 weeks since prior anthracyclines - No prior cumulative dose of doxorubicin more than 360 mg/m^2 - No prior cumulative dose of epirubicin more than 720 mg/m^2 - No prior cumulative dose of mitoxantrone more than 90 mg/m^2 - No other concurrent chemotherapy Endocrine therapy: - More than 2 weeks since prior hormonal therapy in the adjuvant or metastatic setting - No concurrent hormonal therapy Radiotherapy: - See Disease Characteristics - No concurrent radiotherapy Surgery: - Not specified Other: - No other concurrent anticancer therapy or investigational drugs - No concurrent bisphosphonates started after study enrollment except for hypercalcemia

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2013.
Information provided to ClinicalTrials.gov by European Organisation for Research and Treatment of Cancer - EORTC.