Docetaxel and Carboplatin With or Without Trastuzumab Before Surgery in Treating Women With Locally Advanced Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: trastuzumab; carboplatin; docetaxel; trastuzumab
Intervention description: Cycle 5-7 post-op only Day 1 4mg/kg IV Day 8, 15 2mg/kg IV Cycle 8 Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV; Cycle 1-8 Day 1 or 2 AUC = 6 IV; Cycle 1-8 Day 1 or 2: 75 mg/m2 IV; Cycle 1-4 pre-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV
Cycle 5-7 post-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV
Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV
Intervention MeSH terms: Carboplatin; Docetaxel; Trastuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 74.0
Sex: Female
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; stage II breast cancer

Summary:

      RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, use different ways
      to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as
      trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances
      to them without harming normal cells. It is not yet known whether docetaxel and carboplatin
      are more effective with or without trastuzumab in treating breast cancer.

      PURPOSE: This randomized phase II trial is studying how well giving docetaxel together with
      carboplatin and trastuzumab before surgery works compared to docetaxel and carboplatin alone
      before surgery in treating women with locally advanced breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed infiltrating adenocarcinoma of the breast

          -  Primary breast cancer > 5cm, or skin/chest wall involvement, any N, without evidence
             of metastasis.

          -  No prior radiation to the involved breast

          -  ECOG (Electrocochleography) performance status 0-2

          -  Age 18 years to 80 years

          -  Absolute Neutrophil count > 1500 cell/μl, platelet count > 100000 cells/μl and
             hemoglobin > 9 g/dl

          -  All liver function tests < upper limit of normal

          -  Serum creatinine < 2.0 mg/dl

          -  Normal left ventricular ejection fraction (LVEF) as determined by MUGA (Multiple Gated
             Acquisition) scan or echocardiogram

          -  HER-2/neu status is determined by a FISH (Fluorescence in situ hybridization) test.
             [FISH (+) is HER-2/neu (+)]

          -  If female of childbearing potential, pregnancy test is negative

          -  If premenopausal and not surgically sterilized, the patient agrees to use effective
             birth control method for the duration of the study

          -  Informed consent has been obtained

        Exclusion Criteria:

          -  Non-confirmed infiltrating adenocarcinoma breast cancer

          -  Evidence of metastasis

          -  Previous chemotherapy using the drugs proposed in this study, specifically Herceptin®,
             Taxotere®, and/or Carboplatin

          -  Prior radiation to the involved breast

          -  Recent breast cancer drug therapy within last 5 years of any form

          -  History of allergy to polysorbate or castor oil

          -  Ongoing active infection

          -  Concurrent life-limiting disease with a life expectancy of less than one year

          -  Past or current history of other malignancy within the past 5 years which could affect
             the diagnosis or assessment of breast cancer, except for curatively treated
             non-melanoma skin cancer and/or in situ carcinoma of the cervix

          -  Pregnancy, nursing, fertile women who do not use birth control device

          -  Inability to give informed consent

          -  Patients with pre-existing peripheral neuropathy > grade 2