Chemotherapy and Stem Cell Transplantation in Treating Patients With Stage IIIB Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: filgrastim; cisplatin; cyclophosphamide; doxorubicin hydrochloride; melphalan; mesna; paclitaxel; tamoxifen citrate; bone marrow ablation with stem cell support; conventional surgery; peripheral blood stem cell transplantation
Intervention MeSH terms: Tamoxifen; Paclitaxel; Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Melphalan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: stage IIIB breast cancer; inflammatory breast cancer

Summary:

      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: This phase II trial is studying how well chemotherapy and stem cell transplantation
      work in treating patients with stage IIIB breast cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically proven stage IIIB breast cancer with dermal/epidermal invasion or
             clinical features of inflammation, erythema, pain or hypersensitivity, edema, or
             thickening of the skin

          -  Diagnosis within the past 6 months

        PATIENT CHARACTERISTICS:

        Age:

          -  60 and under

        Performance status:

          -  Karnofsky 80-100%

        Life expectancy:

          -  Not specified

        Hematopoietic:

          -  Absolute neutrophil count at least 1,500/mm^3

          -  Platelet count at least 100,000/mm^3

        Hepatic:

          -  Bilirubin less than 1.5 mg/dL

          -  SGOT or SGPT no greater than 1.5 times the upper limit of normal

        Renal:

          -  Creatinine less than 1.2 mg/dL

          -  Creatinine clearance at least 80 mL/min

          -  No history of hemorrhagic cystitis

        Cardiovascular:

          -  Left ventricular fraction at least 55% on MUGA scan

          -  No previous valvular heart disease or arrhythmia

        Pulmonary:

          -  FEV_1 at least 60% predicted

          -  Room air pO_2 greater than 85 mmHg

          -  Room air pCO_2 no greater than 43 mmHg

          -  DLCO at least 60% of the lower limit of predicted value

        Other:

          -  No history of malignant disease in the past 5 years, except for squamous or basal cell
             skin cancer and stage I or in situ cervical cancer

          -  No organic CNS dysfunction

          -  Not pregnant

          -  No known and potentially disabling psychosocial history

          -  Not positive for hepatitis B or HIV

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  Not specified

        Chemotherapy:

          -  Stratum 1:

               -  No more than one cycle of chemotherapy

          -  Stratum 2:

               -  No greater than 225 mg/m^2 doxorubicin and no greater than 250 mg/m^2 paclitaxel
                  during previous chemotherapy

        Endocrine therapy:

          -  Not specified

        Radiotherapy:

          -  No prior radiation to the left chest wall

        Surgery:

          -  Modified radical mastectomy allowed