Trastuzumab and External Beam Radiation Therapy in Treating Women With Stage III or Stage IV Breast Cancer

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: Female

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. Radiation therapy uses high-energy x-rays to kill tumor cells. Trastuzumab may make tumor cells more sensitive to radiation therapy. Giving trastuzumab together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects and how well giving trastuzumab together with external beam radiation therapy works in treating women with stage III or stage IV breast cancer.

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

Details

• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Trastuzumab

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed* invasive primary carcinoma of the breast by fine-needle aspiration, core needle biopsy, or incisional biopsy

• Excisional biopsy is not allowed

• Stage III or IV disease (clinical and radiographic staging), including any of the following:

• Any T with N2 disease (metastasis to ipsilateral axillary lymph nodes fixed to one another or other structures) or N3 disease (metastasis to ipsilateral internal mammary lymph nodes)

• T4, any N disease

• Inflammatory disease

• Supraclavicular and/or infraclavicular adenopathy

• Distant metastasis with measurable disease in the breast or lymph nodes

• HER2-overexpressing tumor

• Measurable or evaluable disease

• Residual locoregional disease after completion of neoadjuvant chemotherapy OR locoregional recurrent disease

• Synchronous bilateral primary cancers allowed provided the more serious of the two cancers meets staging criteria

• Hormone receptor status not specified

PATIENT CHARACTERISTICS:

• Menopausal status not specified

• WBC > 2,000/mm^3

• Platelet count > 50,000/mm^3

• Hemoglobin > 11 g/dL

• Negative pregnancy test

• Fertile patients must use effective contraception

• Radionucleotide ventriculography/LVEF normal OR ≤ 10% asymptomatic decline from baseline after completion of neoadjuvant chemotherapy

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior radiotherapy to the breast or regional lymph nodes

• Concurrent participation in neoadjuvant chemotherapy clinical trials allowed