RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by peripheral stem cell transplantation in treating women who have breast cancer.

Condition	Treatment or Intervention	Phase
stage IIIB breast cancer stage IIIA breast cancer inflammatory breast cancer stage IV breast cancer recurrent breast cancer stage II breast cancer	Drug: carboplatin  Drug: cyclophosphamide  Drug: thiotepa	Phase II

Further Study Details: 

OBJECTIVES: I. Determine long term remission rates as measured by disease free survival in women with breast cancer treated with cyclophosphamide, thiotepa, and carboplatin followed by autologous hematopoietic stem cell transplantation. II. Determine the safety and efficacy of this combination chemotherapy regimen in this patient population.

PROTOCOL OUTLINE: Peripheral blood stem cells (PBSC) are collected. Patients sequentially receive cyclophosphamide IV over 1 hour, thiotepa IV over 1 hour, and carboplatin IV over 1 hour on days -6 to -4. PBSC are reinfused on day 0. Patients are followed at 3 months, 6 months, 1 year, and then annually thereafter.

PROJECTED ACCRUAL: At least 40 patients with 4-9 positive lymph nodes and at least 50 patients with 10 positive lymph nodes will be accrued for this study.

Ages Eligible for Study:  up to  64 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically confirmed breast cancer; Stage II with greater than 3 positive axillary lymph nodes following standard induction chemotherapy, as well as surgery and/or radiation as clinically indicated; Stage III following standard induction chemotherapy with an anthracycline based regimen, and surgery and/or radiation as clinically indicated; Inflammatory carcinoma following standard induction chemotherapy with an anthracycline based regimen, and surgery and/or radiation as clinically indicated; Stage IV metastatic disease that has demonstrated a complete response to an anthracycline containing regimen, or no evidence of disease after surgery or radiation
• Hormone receptor status: Not specified

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: See Disease Characteristics; Prior total dose of doxorubicin or daunorubicin less than 450 mg/m2 unless endometrial biopsy shows less than grade 2 drug effect
• Endocrine therapy: Not specified
• Radiotherapy: See Disease Characteristics
• Surgery: See Disease Characteristics
• Other: No concurrent nitroglycerin preparations for angina pectoris; No concurrent antiarrhythmic drugs for major ventricular dysrrhythmias

--Patient Characteristics--

• Age: 64 and under
• Sex: Female
• Menopausal status: Not specified
• Performance status: ECOG 0-1
• Life expectancy: Not specified
• Hematopoietic: Not specified
• Hepatic: Bilirubin no greater than 2.0 mg/dL; SGOT/SGPT no greater than 2.5 times upper limit of normal; No history of severe hepatic dysfunction
• Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance at least 60 mL/min
• Cardiovascular: No evidence of severe cardiac dysfunction; Ejection fraction at least 50% by MUGA; No major heart disease; Essential hypertension controlled with medications allowed
• Pulmonary: DLCO at least 50% of normal; No symptomatic obstructive or restrictive pulmonary disease
• Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception; No psychosocial disorder that would preclude study compliance; No concurrent active infections; No insulin dependent diabetes mellitus; No uncompensated major thyroid or adrenal dysfunction; No significant skin breakdown from tumor or other disease; HIV negative

Florida
      Florida Cancer Specialists, Fort Myers,  Florida,  33901,  United States
      H. Lee Moffitt Cancer Center and Research Institute, Tampa,  Florida,  33612-9497,  United States
      Halifax Medical Center, Daytona Beach,  Florida,  32114,  United States

Study chairs or principal investigators

Karen K. Fields,  Study Chair,  H. Lee Moffitt Cancer Center and Research Institute   

Study ID Numbers:  CDR0000067768; MCC-11072; NCI-G00-1760; MCC-IRB-3898
Record last reviewed:  March 2004
Last Updated:  October 13, 2004
Record first received:  June 2, 2000
ClinicalTrials.gov Identifier:  NCT00005798
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08