Combination Chemotherapy With or Without Trastuzumab in Treating Patients With Stage II or Stage III Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: cyclophosphamide; docetaxel; doxorubicin hydrochloride; Trastuzumab; Carboplatin; Paclitaxel
Intervention description: Given IV; Given IV; Given IV; Given IV; Given IV; Given IV
Intervention MeSH terms: Paclitaxel; Docetaxel; Cyclophosphamide; Carboplatin; Doxorubicin; Liposomal doxorubicin; Trastuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 121.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: inflammatory breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; male breast cancer; Paget disease of the breast with invasive ductal carcinoma; invasive ductal breast carcinoma with predominant intraductal component; invasive ductal breast carcinoma; medullary ductal breast carcinoma with lymphocytic infiltrate; comedo ductal breast carcinoma; invasive lobular breast carcinoma with predominant in situ component; invasive lobular breast carcinoma; mucinous ductal breast carcinoma; papillary ductal breast carcinoma; tubular ductal breast carcinoma

Summary:

      RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor
      cells, either by killing the cells or by stopping them from dividing. Giving more than one
      drug (combination chemotherapy) may kill more tumor cells. 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. Giving combination chemotherapy with or without trastuzumab before
      surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be
      removed. It is not yet known whether combination chemotherapy is more effective with or
      without trastuzumab in treating breast cancer.

      PURPOSE: This randomized phase II trial is comparing two different regimens of combination
      chemotherapy given together with or without trastuzumab to see how well they work in treating
      patients with stage II or stage III breast cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically proven infiltrating ductal or lobular breast carcinoma

               -  Stage II or III disease

               -  Inflammatory breast cancer allowed

          -  Hormone-receptor status not specified

        PATIENT CHARACTERISTICS:

          -  ECOG performance status < 2

          -  Male or female

          -  Menopausal status not specified (for female patients)

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Bilirubin normal (except for patient's with Gilbert's disease)

          -  Creatinine ≤ 1.2 mg/dL

          -  Creatinine clearance ≥ 70 mL/min

          -  Ejection fraction ≥ 50% on MUGA

          -  No neuropathy ≥ grade 1

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective nonhormonal contraception

          -  No prior malignant disease within the past 5 years, excluding:

               -  Squamous cell or basal cell skin carcinoma

               -  Stage I or in situ cervical carcinoma

          -  No noninvasive (in situ) breast carcinoma within the past 5 years

        PRIOR CONCURRENT THERAPY:

          -  At least 5 years since prior antiestrogen treatment for any indication other than
             breast cancer prevention (tamoxifen, raloxifene, or an aromatase inhibitor)

          -  No prior radiotherapy to the chest wall