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RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining monoclonal antibody therapy with radiation therapy may be an effective treatment for breast cancer.
PURPOSE: Phase II trial to study the effectiveness of combining trastuzumab and radiation therapy in treating women who have stage III or stage IV invasive primary cancer of the breast.
OBJECTIVES: I. Determine the tolerability of trastuzumab (Herceptin) and radiotherapy in women with stage III or IV invasive primary carcinoma of the breast that continues to overexpress HER2 following neoadjuvant systemic chemotherapy. II. Determine the pathologic response rate, locoregional recurrence rate, and time to locoregional recurrence in patients treated with this regimen who did not achieve clinical complete remission following neoadjuvant systemic chemotherapy.
OUTLINE: Patients who received trastuzumab (Herceptin) in combination with prior neoadjuvant chemotherapy receive trastuzumab IV over 30 minutes on day 1, followed by radiotherapy on days 1-5. Patients who did not receive trastuzumab in combination with prior neoadjuvant chemotherapy receive a loading dose of trastuzumab IV over 90 minutes, followed one week later by trastuzumab IV over 30 minutes on day 1, followed by radiotherapy on days 1-5. Radiotherapy begins within 3-4 weeks after completion of neoadjuvant chemotherapy. Treatment continues weekly for 5 courses in the absence of unacceptable toxicity. Patients are followed at 3 weeks for surgical resectability, then every 3 months for 2 years, and then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 18-35 patients will be accrued for this study.
Primary Purpose: Treatment
trastuzumab, radiation therapy
Lineberger Comprehensive Cancer Center, UNC
Active, not recruiting
National Cancer Institute (NCI)
Published on BioPortfolio: 2014-08-27T03:57:30-0400
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 ...
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether radiation therapy directed at the head is effective in preventing brain metastases in ...
Trastuzumab and Trastuzumab-MCC-DM1 Administered Intravenously and GDC-0941 Administered Orally to Patients With HER2-Positive Metastatic Breast Cancer Who Have Progressed on Previous Trastuzumab-Based Therapy
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Abnormal accumulation of lymph in the arm, shoulder and breast area associated with surgical or radiation breast cancer treatments (e.g., MASTECTOMY).
A humanized monoclonal antibody against the ERBB-2 RECEPTOR (HER2). As an ANTINEOPLASTIC AGENT, it is used to treat BREAST CANCER where HER2 is overexpressed.
Preliminary cancer therapy (chemotherapy, radiation therapy, hormone/endocrine therapy, immunotherapy, hyperthermia, etc.) that precedes a necessary second modality of treatment.
Metastatic breast cancer characterized by EDEMA and ERYTHEMA of the affected breast due to LYMPHATIC METASTASIS and eventual obstruction of LYMPHATIC VESSELS by the cancer cells.
Drug therapy given to augment or stimulate some other form of treatment such as surgery or radiation therapy. Adjuvant chemotherapy is commonly used in the therapy of cancer and can be administered before or after the primary treatment.
Track and monitor developments in breast cancer research and commercial development. Follow the tabs above to read the latest global news, research, clinical trials on breast cancer and follow companies active in the development of breast cancer tr...
In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...