Trastuzumab, Docetaxel, and Carboplatin in Treating Women With Stage II, Stage III, or Inflammatory Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms; Inflammatory Breast Neoplasms
Intervention: herceptin; carboplatin; docetaxel; conventional surgery; radiation therapy
Intervention description: Modified radical mastectomy or lumpectomy and axillary node dissection; Whole breast or chest wall irradiation (as determined by radiologist)
Intervention MeSH terms: Carboplatin; Docetaxel; Trastuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: inflammatory breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer

Summary:

      RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different
      ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and
      help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as
      docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either
      by killing the cells or by stopping them from dividing. Giving trastuzumab together with
      docetaxel and carboplatin may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving trastuzumab together with docetaxel
      and carboplatin works in treating women with stage II, stage III, or inflammatory breast
      cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed breast cancer, meeting 1 of the following stage criteria:

               -  Stage IIB (T3, N0)

               -  Stage IIIA (N0-N2)

               -  Stage IIIB (T4, N0-2)

               -  Stage IIIC

               -  Inflammatory breast cancer

          -  HER2/neu-positive disease by fluorescence in situ hybridization

          -  Biopsy-accessible tumor

          -  Measurable disease by physical examination or x-ray

          -  No stage IV disease

          -  Hormone receptor status:

               -  Not specified

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Sex

          -  Female

        Menopausal status

          -  Not specified

        Performance status

          -  ECOG 0-2

        Life expectancy

          -  At least 8 weeks

        Hematopoietic

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

        Hepatic

          -  Meets 1 of the following criteria:

               -  SGOT and SGPT ≤ 5 times upper limit of normal (ULN) AND alkaline phosphatase
                  normal

               -  SGOT and SGPT ≤ 1.5 times ULN AND alkaline phosphatase ≤ 2.5 times ULN

               -  SGOT and SGPT normal AND alkaline phosphatase ≤ 5 times ULN

          -  Bilirubin normal

        Renal

          -  Creatinine normal

          -  No pre-existing clinically significant renal disease that is not related to the
             malignancy

        Cardiovascular

          -  Ejection fraction ≥ 50% by MUGA

          -  No pre-existing clinically significant cardiac disease that is not related to the
             malignancy

          -  No history of congestive heart failure

        Pulmonary

          -  No pre-existing clinically significant pulmonary disease that is not related to the
             malignancy

        Gastrointestinal

          -  No severe malnutrition

          -  No intractable emesis

        Neurologic

          -  No pre-existing clinically significant neurologic disease that is not related to the
             malignancy

          -  No peripheral neuropathy ≥ grade 2

               -  No nerve damage from diabetes

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective non-hormonal contraception during and for 4 weeks
             after completion of study treatment

          -  No known allergic reaction to study drugs

          -  No active infection

          -  No other malignancy except adequately treated basal cell or squamous cell skin cancer
             or carcinoma in situ of the cervix

          -  No other pre-existing clinically significant disease that is not related to the
             malignancy

          -  No other serious or significant medical condition that would preclude study
             participation

          -  No other contraindication to study treatment

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  No other concurrent immunotherapy

        Chemotherapy

          -  No prior chemotherapy for the malignancy

          -  No other concurrent chemotherapy

        Endocrine therapy

          -  No concurrent hormonal therapy for the malignancy

        Radiotherapy

          -  No concurrent radiotherapy

        Surgery

          -  No concurrent surgery for the malignancy

        Other

          -  More than 2 weeks since prior and no concurrent herbal remedies or aspirin-containing
             products

          -  No other concurrent investigational or commercial agents or therapies for the
             malignancy