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Home > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Patients With High-Risk Breast Cancer  Combination Chemotherapy in Treating Patients With High-Risk Breast Cancer
Combination Chemotherapy in Treating Patients With High-Risk Breast Cancer
For Condition: stage 3A breast cancer,stage 2 breast cancer,stage 3B breast cancer
Status: Recruiting
Sponsor(s): Beckman Research Institute , National Cancer Institute (NCI)
Synopsis: 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: Randomizedphase II trial to compare the effectiveness of two regimens of combination chemotherapy in treating patients who have high-risk primarystage II or stage III breast cancer.
Details: 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 temporarily closed as of 12/12/2002.) - 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, all 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 temporarily closed as of 12/12/2002.) - Arm I (ACT): 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 I temporarily closed as of 12/12/2002). - 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /60 Years
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GeorgeSomlo, Study Chair, Beckman Research Institute
Good Samaritan Regional Medical Center *Recruiting*
Phoenix, Arizona, 85006
United States
Recruiting Jeffrey Schriber 602-239-4526
City of Hope Comprehensive Cancer Center *Recruiting*
Duarte, California, 91010-3000
United States
Recruiting George Somlo 626-359-8111
Additional Information:
Study ID Numbers: CDR0000067305; CHNMC-IRB-98096,CHNMC-PHII-18,NCI-H99-0038
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004092
Other Stage 2 Breast Cancer Studies:
1. Combination Chemotherapy in Treating Women With Breast Cancer
2. Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer
3. Combination Chemotherapy and Filgrastim Followed by Radiation Therapy in Treating Patients With Stage II or Stage IIIA Breast Cancer
4. Comparison of Complete Axillary Lymph Node Dissection With Axillary Radiation Therapy in Treating Women With Invasive Breast Cancer
5. Assessing Women's Attitudes About the Risk of Infertility Related to Adjuvant Therapy for Early Breast Cancer
Related Studies:
Other stage 2 breast cancer Clinical Trials
Other Arizona Clinical Trials
Other Phoenix Clinical Trials
Combination Chemotherapy in Treating Patients With High-Risk Breast Cancer
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