Radiation Therapy to the Head in Preventing Brain Metastases in Women Receiving Trastuzumab and Chemotherapy for Metastatic or Locally Advanced Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00639366|
Recruitment Status : Completed
First Posted : March 20, 2008
Last Update Posted : August 7, 2013
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 patients with advanced cancer.
PURPOSE: This randomized phase III trial is studying radiation therapy to the head to see how well it works in preventing brain metastases in women receiving trastuzumab and chemotherapy for metastatic or locally advanced breast cancer.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Biological: trastuzumab Drug: chemotherapy Radiation: radiation therapy||Phase 3|
- To test if prophylactic cranial radiotherapy delivering 30 Gy in 10 fractions will significantly reduce (from 35% to 21% at 2 years) the incidence of symptomatic brain metastases in patients treated with trastuzumab (Herceptin®) for metastatic breast cancer.
OUTLINE: This is a multicenter study. Patients are stratified by center, type of systemic therapy (trastuzumab [Herceptin®] monotherapy vs combination with chemotherapy), hormone receptor status, and presence of lung metastases (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive taxane/trastuzumab therapy for 6 weeks. While continuing taxane/trastuzumab therapy, patients then undergo 10 fractions of concurrent prophylactic cranial radiotherapy in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive taxane/trastuzumab therapy without concurrent prophylactic cranial radiotherapy.
All patients undergo quality of life assessments every 8 weeks for 9 months.
After completion of study treatment, patients are followed periodically for at least 1 year.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||390 participants|
|Official Title:||Prospective Randomised Clinical Trial Testing the Role of Prophylactic Cranial Radiotherapy in Patients Treated With Trastuzumab (Herceptin®) for Metastatic Breast Cancer|
|Study Start Date :||February 2007|
|Actual Primary Completion Date :||February 2010|
|Actual Study Completion Date :||October 2010|
- Incidence of symptomatic brain metastases
- Cerebral toxicity and quality of life
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00639366
|Principal Investigator:||Peter A. Canney, MD||University of Glasgow|