Multimodality Treatment for Women With Stage II, Stage III, or Stage IV Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: trastuzumab; cyclophosphamide; doxorubicin hydrochloride; paclitaxel; conventional surgery
Intervention description: infusion 4 mg/kg load week 1; 2 mg/kg weekly thereafter for 12 weeks; 600 mg/m2, intravenous infusion every 3 weeks for four cycles; 60 mg/m2 intravenously, 5-10 minutes, every 3 weeks, up to 12 weeks; 90 mg/m2 weekly, intravenously 1 hour after herceptin, given weekly up to 12 weeks or 175 mg/m2, intravenously every 3 weeks, up to 12 weeks (only if not receiving Herceptin®); Surgical excision will take place 12-13 weeks for the neo-adjuvant herceptin setting and 12-13 weeks in the non-herceptin setting. Surgery will take place prior to chemotherapy in the adjuvant herceptin setting
Intervention MeSH terms: Paclitaxel; Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Trastuzumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 82.0
Sex: Female
Minimum age: 1 Year
Maximum age: 120 Years
Healthy volunteers: No
Keywords: stage II breast cancer; stage IV breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC 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. Monoclonal antibodies such as trastuzumab can locate tumor cells
      and either kill them or deliver tumor-killing substances to them without harming normal
      cells. Combining chemotherapy, monoclonal antibody therapy, and surgery may be a more
      effective treatment for breast cancer.

      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, monoclonal
      antibody therapy, and surgery in treating women who have stage II, stage III, or stage IV
      breast cancer.
    

Eligibility criteria:

        Inclusion Criteria

          -  Histologically confirmed stage IIB, IIIA, IIIB, IIIC, or previously untreated stage IV
             primary carcinoma of the breast

               -  Fine needle aspiration, core needle biopsy, or incisional biopsy allowed

               -  No excisional biopsy

               -  Any of the following:

                    -  Tumor size 2, Nodes 1 (T2N1) or tumor size 3 nodes 0 (T3N0)

                    -  Any T with N2 (including axillary lymph nodes matted to one another) or N3

                    -  Any T4, including inflammatory breast cancer

                    -  Adjuvant patients with at least 4 positive lymph nodes and HER-2
                       overexpressing tumor

                    -  Supraclavicular or infraclavicular positive lymph nodes without distant
                       metastases

                    -  Distant metastases with measurable disease in breast or lymph nodes

          -  Synchronous bilateral primary breast cancer allowed if the more serious cancer meets
             entry criteria

          -  Measurable or evaluable disease

        PATIENT CHARACTERISTICS:

        Age: Not specified

        Sex: Female

        Menopausal status: Not specified

        Performance status: Not specified

        Life expectancy: Not specified

        Hematopoietic:

        White cell count > 3000 / mm3 Platelet count > 100,000 / mm3

        Hemoglobin > 9 mg / dl Bilirubin < 1.5 x normal Creatinine < 1.5 x normal left ventricular
        ejection fraction (LVEF) normal by resting nuclear ventriculogram Not pregnant or nursing
        Negative pregnancy test Fertile patients must use effective contraception

        Exclusions

        Prior malignancies except:

        Effectively treated squamous cell or basal cell skin cancer Carcinoma in situ of the cervix
        that has been curatively treated by surgery alone Nonbreast malignancy from which patient
        has been disease-free for 5 years and is at low risk of recurrence