Combination Chemotherapy in Treating Patients With High-Risk Breast Cancer

• Status: Completed
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: City of Hope Medical Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Carboplatin; Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Paclitaxel; Thiotepa

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