Randomized Phase II Study of Adriamycin/Cytoxan/Taxol (ACT) vs. Cytoxan, Thiotepa, Carboplatin (STAMP V) in Patients With High-Risk Primary Breast Cancer
filgrastim
+ cyclophosphamide
+ doxorubicin hydrochloride
Breast Diseases+3
+ Neoplasms
+ Neoplasms by Site
Treatment Study
Summary
Study start date: May 1, 1999
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.72 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Until 60 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Banner Good Samaritan Medical Center
Phoenix, United StatesOpen Banner Good Samaritan Medical Center in Google MapsCity of Hope Comprehensive Cancer Center
Duarte, United States