NCT00943410

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

Phase II Trial of Herceptin Concurrent With External Beam Radiation Following Neoadjuvant Chemotherapy for the Treatment of HER2 Over-Expressing Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: UNC Lineberger Comprehensive Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

OBJECTIVES: Primary * Determine the tolerability of trastuzumab (Herceptin®) and concurrent external beam radiotherapy in women with HER2-overexpressing stage III or IV breast cancer. Secondary * Determine the pathologic response rate in patients treated with this regimen. * Determine the locoregional recurrence rate (as site of first recurrence or any recurrence) and time to locoregional recurrence in patients treated with this regimen. * Determine the time to local progression in patients (who are deemed to be non-surgical candidates) treated with this regimen . OUTLINE: This is a multicenter study. Patients receive trastuzumab IV over 30-90 minutes once a week for 5 weeks. Patients also undergo external beam radiotherapy once daily 5 days a week for 5 weeks. Three weeks after the completion of trastuzumab and radiotherapy, patients undergo surgical evaluation. Patients deemed to be surgical candidates undergo surgery. Patients deemed to be non-surgical candidates continue to receive trastuzumab and external beam radiotherapy for 2 additional weeks. After completion of study therapy, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
RADIATION	external beam radiation therapy	Radiation therapy will consist of 50Gy in 2Gy fractions to the breast/chest wall and regional lymphatics for 5 consecutive days up to 5 weeks for surgical candidates and 7 weeks for non-surgical candidates
DRUG	Herceptin	Patients who are already receiving weekly Herceptin® will continue weekly Herceptin®, 2mg/kg IV on day 1 of each week of radiotherapy. Patients who have not been receiving weekly Herceptin® as a component of systemic therapy will begin Herceptin® one week prior to beginning radiotherapy with a loading dose of 4mg/kg followed by weekly Herceptin® at 2mg/kg on day 1 of each week of radiotherapy

Timeline

• Start date: 2000-03-01
• Primary completion: 2006-01-01
• Completion: 2009-07-01
• First posted: 2009-07-22
• Last updated: 2012-08-15