Radiation Therapy to the Head in Preventing Brain Metastases in Women Receiving Trastuzumab and Chemotherapy for Metastatic or Locally Advanced Breast Cancer
NCT ID: NCT00639366
Last Updated: 2013-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
390 participants
INTERVENTIONAL
2007-02-28
2010-10-31
Brief Summary
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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
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* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PREVENTION
Interventions
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trastuzumab
chemotherapy
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Anglo Celtic Cooperative Oncology Group
OTHER
Principal Investigators
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Peter A. Canney, MD
Role: PRINCIPAL_INVESTIGATOR
University of Glasgow
Locations
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Basildon University Hospital
Basildon, England, United Kingdom
Ipswich Hospital
Ipswich, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom
Royal Liverpool University Hospital
Liverpool, England, United Kingdom
Aintree University Hospital
Liverpool, England, United Kingdom
Barts and the London School of Medicine
London, England, United Kingdom
Christie Hospital
Manchester, England, United Kingdom
Clatterbridge Centre for Oncology
Merseyside, 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
Cancer Care Centre at York Hospital
York, England, United Kingdom
Dumfries & Galloway Royal Infirmary
Dumfries, Scotland, United Kingdom
Ninewells Hospital
Dundee, 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
Countries
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Other Identifiers
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CDR0000588868
Identifier Type: REGISTRY
Identifier Source: secondary_id
ISRCTN64624715
Identifier Type: -
Identifier Source: secondary_id
EU-20822
Identifier Type: -
Identifier Source: secondary_id
ACCOG-HER-PCI
Identifier Type: -
Identifier Source: org_study_id