Multimodality Treatment for Women With Stage II, Stage III, or Stage IV Breast Cancer

• Status: Completed
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center
• Treatments: Albumin-Bound Paclitaxel; Cyclophosphamide; Doxorubicin; Liposomal doxorubicin; Paclitaxel; Trastuzumab

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