Radiation Therapy to the Head in Preventing Brain Metastases in Women Receiving Trastuzumab and Chemotherapy for Metastatic or Locally Advanced Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT00639366
- Lead Sponsor
- Anglo Celtic Cooperative Oncology Group
- Brief Summary
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.
- Detailed Description
OBJECTIVES:
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 390
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of symptomatic brain metastases
- Secondary Outcome Measures
Name Time Method Survival Cerebral toxicity and quality of life
Trial Locations
- Locations (19)
Ipswich Hospital
🇬🇧Ipswich, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
🇬🇧Leeds, England, United Kingdom
Basildon University Hospital
🇬🇧Basildon, England, United Kingdom
Cancer Care Centre at York Hospital
🇬🇧York, England, United Kingdom
Ninewells Hospital
🇬🇧Dundee, Scotland, United Kingdom
Clatterbridge Centre for Oncology
🇬🇧Merseyside, England, United Kingdom
Christie Hospital
🇬🇧Manchester, England, United Kingdom
Barts and the London School of Medicine
🇬🇧London, England, United Kingdom
Aintree University Hospital
🇬🇧Liverpool, England, United Kingdom
Cancer Research Centre at Weston Park Hospital
🇬🇧Sheffield, England, United Kingdom
Great Western Hospital
🇬🇧Swindon, England, United Kingdom
Southend University Hospital NHS Foundation Trust
🇬🇧Westcliff-On-Sea, England, United Kingdom
Dumfries & Galloway Royal Infirmary
🇬🇧Dumfries, Scotland, United Kingdom
Edinburgh Cancer Centre at Western General Hospital
🇬🇧Edinburgh, Scotland, United Kingdom
Falkirk and District Royal Infirmary
🇬🇧Falkirk, Scotland, United Kingdom
Beatson West of Scotland Cancer Centre
🇬🇧Glasgow, Scotland, United Kingdom
Crosshouse Hospital
🇬🇧Kilmarnock, Scotland, United Kingdom
Wishaw General Hospital
🇬🇧Wishaw, Scotland, United Kingdom
Royal Liverpool University Hospital
🇬🇧Liverpool, England, United Kingdom