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Home > "C" Clinical Trials Conditions > Combination Chemotherapy With Trastuzumab in Treating Women With Metastatic Breast Cancer  Combination Chemotherapy With Trastuzumab in Treating Women With Metastatic Breast Cancer
Combination Chemotherapy With Trastuzumab in Treating Women With Metastatic Breast Cancer
For Condition: stage 4 breast cancer,recurrent breast cancer
Status: Recruiting
Sponsor(s): EORTC Breast Cancer Cooperative Group , National Cancer Institute (NCI),EORTC New Drug Development Group
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
LauraBiganzoli, , Institut Jules Bordet
Medical Oncology Centre of Rosebank *Recruiting*
Johannesburg, , 2193
South Africa
Recruiting Contact Person 27-880-4222
National Cancer Institute of Egypt *Recruiting*
Cairo, ,
Egypt
Recruiting Contact Person 20-364-3661
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology *Recruiting*
Warsaw, , 02-781
Poland
Recruiting Contact Person 048-58-41-62-26
Clinique Sainte Elisabeth *Recruiting*
Namur, , 5000
Belgium
Recruiting Contact Person 32-72-0411
Leiden University Medical Center *Recruiting*
Leiden, , 2300 CA
Netherlands
Recruiting Contact Person 31-52-6911
University Medical Center Nijmegen *Recruiting*
Nijmegen, , NL-6500 HB
Netherlands
Recruiting Contact Person 31- 439-1911
Algemeen Ziekenhuis Sint-Augustinus *Recruiting*
Wilrijk, , 2610
Belgium
Recruiting Contact Person 32-443-3011
Institut Jules Bordet *Recruiting*
Brussels, , 1000
Belgium
Recruiting Contact Person 32-541-3111
Maria S. Curie Memorial Institute *Recruiting*
Gliwice, , 44-101
Poland
Recruiting Contact Person 48-32-278-8717
Algemeen Ziekenhuis Middelheim *Recruiting*
Antwerp, , 2020
Belgium
Recruiting Contact Person 32-280-3111
CRLCC Nantes - Atlantique *Recruiting*
Nantes-Saint Herblain, , 44805
France
Recruiting Contact Person 33-24-067-9977
Universitair Ziekenhuis Antwerpen *Recruiting*
Edegem, , B-2650
Belgium
Recruiting Contact Person 32-821-3000
Centre Hospitalier Etterbeek Ixelles *Recruiting*
Brussels, , B-1050
Belgium
Recruiting Contact Person 32-641-4111
Onze Lieve Vrouwe Gasthuis *Recruiting*
Amsterdam, , 1091 HA
Netherlands
Recruiting Contact Person 31-10-439-1911
Daniel Den Hoed Cancer Center at Erasmus Medical Center *Recruiting*
Rotterdam, , 3008 AE
Netherlands
Recruiting Contact Person 31-10-439-1911
Medical University of Gdansk *Recruiting*
Gdansk, , 80-211
Poland
Recruiting Contact Person 48-349-2222
Institute of Oncology and Radiology of Serbia *Recruiting*
Belgrade, , 11000
Yugoslavia
Recruiting Contact Person 381-361-4660
Herlev Hospital - University Hospital of Copenhagen *Recruiting*
Copenhagen, , DK-2730
Denmark
Recruiting Contact Person 45-445-35300
Additional Information:
Study ID Numbers: CDR0000069332; EORTC-16999,IDBBC-EORTC-10995,EORTC-10995
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00036868
Other Stage 4 Breast Cancer Studies:
1. BMS-247550 in Treating Women With Metastatic Breast Cancer
2. Bevacizumab in Treating Patients With Metastatic Breast or Colorectal Cancer Who Received Bevacizumab on a Phase II or Phase III Clinical Trial
3. Mitoxantrone With or Without Docetaxel in Treating Women With Metastatic Breast Cancer
4. Irinotecan and Docetaxel in Treating Patients With Refractory Metastatic Breast Cancer
5. Gemcitabine and Liposomal Doxorubicin in Treating Women With Metastatic Breast Cancer
Related Studies:
Other stage 4 breast cancer Clinical Trials
Other Clinical Trials
Other Belgrade Clinical Trials
Combination Chemotherapy With Trastuzumab in Treating Women With Metastatic Breast Cancer
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