Combination Chemotherapy in Treating Patients With High-Risk Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: filgrastim; carboplatin; cyclophosphamide; doxorubicin hydrochloride; paclitaxel; thiotepa; peripheral blood stem cell transplantation
Intervention description: Given IV or subcutaneously; Given IV; Given IV; Given IV; Given IV; Given IV; Patients receive autologous peripheral blood stem cells
Intervention MeSH terms: Paclitaxel; Cyclophosphamide; Carboplatin; Doxorubicin; Liposomal doxorubicin; Thiotepa
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 72.0
Sex: All
Maximum age: 60 Years
Healthy volunteers: No
Keywords: stage II breast cancer; stage IIIA breast cancer; stage IIIB 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.
    

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