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Trastuzumab and Radiation Therapy in Treating Women With Stage III or Stage IV Invasive Primary Cancer of the Breast

2014-08-27 03:57:30 | BioPortfolio

Summary

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.

Description

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.

Study Design

Primary Purpose: Treatment

Conditions

Breast Cancer

Intervention

trastuzumab, radiation therapy

Location

Lineberger Comprehensive Cancer Center, UNC
Chapel Hill
North Carolina
United States
27599-7295

Status

Active, not recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:57:30-0400

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Medical and Biotech [MESH] Definitions

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.

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