Breast Cancer Clinical Trial
Combination Chemotherapy in Treating Patients With High-Risk Breast Cancer
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying two different regimens of combination chemotherapy and comparing them to see how well they work in treating patients with high-risk primary stage II or stage III breast cancer.
Full Description
OBJECTIVES:
Compare the toxic effects of doxorubicin, cyclophosphamide, and paclitaxel vs cyclophosphamide, thiotepa, and carboplatin in patients with high-risk primary breast cancer. (Arm I closed to accural as of 4/6/2006.)
Compare the efficacies of these regimens followed by peripheral blood stem cell rescue in these patients.
Determine the efficacy of a bisphosphonate to prevent relapse/metastasis after high-dose chemotherapy in these patients.
OUTLINE: This is a randomized study. Patients are stratified by stage of disease.
Peripheral blood stem cells (PBSC) are collected after mobilization with filgrastim (G-CSF), administered subcutaneously or IV, twice daily beginning 3 days before collection and continuing until collection is complete.
All patients receive conventional-dose adjuvant chemotherapy, probably comprising doxorubicin IV, cyclophosphamide IV, and fluorouracil IV over 1 hour on days 1, 22, 43, and 64. Patients are then randomized to receive 1 of 2 treatment arms of high-dose chemotherapy. (Arm I closed to accrual as of 4/6/2006.)
Arm I (ACT) (closed to accrual as of 4/6/2006): Patients receive doxorubicin IV over 24 hours on days -9 to -6, cyclophosphamide IV over 2 hours on day -5, and paclitaxel IV over 24 hours on day -2. PBSC are reinfused on days -2 and 0. G-CSF is administered beginning on day 0 and continuing until blood counts recover.
Arm II (STAMP V): Patients receive cyclophosphamide IV, carboplatin IV, and thiotepa IV over 24 hours on days -7 to -4. PBSC are reinfused and G-CSF is administered as in arm I.
Within 4-6 weeks of day 0 of high-dose chemotherapy, patients with estrogen and/or progesterone receptor positive tumors receive oral tamoxifen twice daily for 5 years. Patients are also randomized to receive a bisphosphonate comprising pamidronate IV every 4 weeks for 2 years.
Quality of life is assessed before therapy, at 30 days after high-dose chemotherapy, and at 6 and 12 months.
Patients are followed every 3 months for 1 year and then every 6 months for at least 10 years.
PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study within 3 years.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically proven high-risk primary breast cancer with less than 60% chance of progression-free survival of 3 years from diagnosis
Stage II with at least 10 positive axillary nodes OR
Stage IIIA or IIIB
No histologically proven bone marrow metastasis
No CNS metastasis
Hormone receptor status:
Hormone receptor status known
PATIENT CHARACTERISTICS:
Age:
Physiological age 60 or under
Menopausal status:
Not specified
Performance status:
Karnofsky 80-100%
Life expectancy:
See Disease Characteristics
Hematopoietic:
Neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
Hepatic:
Bilirubin no greater than 1.5 mg/dL
SGOT or SGPT no greater than 2 times upper limit of normal
Hepatitis B antigen negative
Renal:
Creatinine no greater than 1.2 mg/dL
Creatinine clearance at least 70 mL/min
No prior hemorrhagic cystitis
Cardiovascular:
Ejection fraction at least 55% by MUGA
No prior significant valvular heart disease or arrhythmia
Pulmonary:
FEV_1 at least 60% of predicted
pO_2 at least 85 mm Hg on room air
pCO_2 at least 43 mm Hg on room air
DLCO at least 60% lower limit of predicted
Other:
No other prior malignancy except squamous cell or basal cell skin cancer or stage I or carcinoma in situ of the cervix
No CNS dysfunction that would preclude compliance
HIV negative
No sensitivity to E. coli-derived products
Not pregnant
Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Not specified
Chemotherapy:
At least 4 weeks since prior chemotherapy
No prior doxorubicin of total dose exceeding 240 mg/m^2
No prior paclitaxel of total dose of at least 750 mg/m^2
No more than 12 months since prior conventional-dose adjuvant chemotherapy
Endocrine therapy:
At least 4 weeks since prior hormonal therapy
Radiotherapy:
At least 4 weeks since prior radiotherapy
No prior radiation to the left chest wall
Surgery:
Not specified
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There are 2 Locations for this study
Phoenix Arizona, 85006, United States
Duarte California, 91010, United States
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