Status:
COMPLETED
Radiation Therapy to the Head in Preventing Brain Metastases in Women Receiving Trastuzumab and Chemotherapy for Metastatic or Locally Advanced Breast Cancer
Lead Sponsor:
Anglo Celtic Cooperative Oncology Group
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
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 wit...
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 pat...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically proven breast carcinoma
- Metastatic or locally advanced disease
- Must demonstrate HER2 3+ positivity on IHC or 2+ over-expression and FISH test demonstrating C-erB2 gene amplification
- No known or suspected brain metastases or CNS disease, as defined by the presence of any of the following key symptoms:
- Headache
- Nausea and/or vomiting
- Clinical signs of raised intracranial pressure
- Seizures
- Focal symptoms
- Cognitive dysfunction
- Affective disorder
- Hormone receptor status not specified
- PATIENT CHARACTERISTICS:
- Female
- Postmenopausal status not specified
- ECOG performance status 0 or 1
- Patients must a-priori be suitable for trastuzumab (Herceptin®) +/- chemotherapy in terms of bone marrow, hepatic, and renal function
- No prior history of cerebrovascular disease or neurological disorder including seizures
- PRIOR CONCURRENT THERAPY:
- No prior cranial radiotherapy
- No prior neurosurgery
Exclusion
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2010
Estimated Enrollment :
390 Patients enrolled
Trial Details
Trial ID
NCT00639366
Start Date
February 1 2007
End Date
October 1 2010
Last Update
August 7 2013
Active Locations (19)
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1
Basildon University Hospital
Basildon, England, United Kingdom, SS16 5NL
2
Ipswich Hospital
Ipswich, England, United Kingdom, IP4 5PD
3
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom, LS9 7TF
4
Royal Liverpool University Hospital
Liverpool, England, United Kingdom, L7 8XP