Radiation Therapy to the Head in Preventing Brain Metastases in Women Receiving Trastuzumab and Chemotherapy for Metastatic or Locally Advanced Breast Cancer
|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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00639366
|Basildon University Hospital|
|Basildon, England, United Kingdom, SS16 5NL|
|Ipswich, England, United Kingdom, IP4 5PD|
|Leeds Cancer Centre at St. James's University Hospital|
|Leeds, England, United Kingdom, LS9 7TF|
|Royal Liverpool University Hospital|
|Liverpool, England, United Kingdom, L7 8XP|
|Aintree University Hospital|
|Liverpool, England, United Kingdom, L9 7AL|
|Barts and the London School of Medicine|
|London, England, United Kingdom, EC1M 6BQ|
|Manchester, England, United Kingdom, M20 4BX|
|Clatterbridge Centre for Oncology|
|Merseyside, England, United Kingdom, CH63 4JY|
|Cancer Research Centre at Weston Park Hospital|
|Sheffield, England, United Kingdom, S1O 2SJ|
|Great Western Hospital|
|Swindon, England, United Kingdom, SN3 6BB|
|Southend University Hospital NHS Foundation Trust|
|Westcliff-On-Sea, England, United Kingdom, SS0 0RY|
|Cancer Care Centre at York Hospital|
|York, England, United Kingdom, Y031 8HE|
|Dumfries & Galloway Royal Infirmary|
|Dumfries, Scotland, United Kingdom, DG1 4AP|
|Dundee, Scotland, United Kingdom, DD1 9SY|
|Edinburgh Cancer Centre at Western General Hospital|
|Edinburgh, Scotland, United Kingdom, EH4 2XU|
|Falkirk and District Royal Infirmary|
|Falkirk, Scotland, United Kingdom, FK1 5QE|
|Beatson West of Scotland Cancer Centre|
|Glasgow, Scotland, United Kingdom, G12 0YN|
|Kilmarnock, Scotland, United Kingdom, KA2 OBE|
|Wishaw General Hospital|
|Wishaw, Scotland, United Kingdom, ML2 0DP|
|Principal Investigator:||Peter A. Canney, MD||University of Glasgow|