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Radiation Therapy to the Head in Preventing Brain Metastases in Women Receiving Trastuzumab and Chemotherapy for Metastatic or Locally Advanced Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00639366
First received: March 19, 2008
Last updated: December 3, 2009
Last verified: December 2008
History of Changes
  Purpose

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 Intervention Phase
Breast Cancer
 Biological: trastuzumab
Drug: chemotherapy
Radiation: radiation therapy
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Prevention
Official Title: Prospective Randomised Clinical Trial Testing the Role of Prophylactic Cranial Radiotherapy in Patients Treated With Trastuzumab (Herceptin®) for Metastatic Breast Cancer

Resource links provided by NLM:

Drug Information available for: Trastuzumab
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Incidence of symptomatic brain metastases [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Survival [ Designated as safety issue: No ]
  • Cerebral toxicity and quality of life [ Designated as safety issue: Yes ]

Estimated Enrollment: 390
Study Start Date: February 2007
Estimated Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00639366

Locations
United Kingdom
Basildon University Hospital Recruiting
Basildon, England, United Kingdom, SS16 5NL
Contact: Contact Person     Not Available        
Ipswich Hospital Recruiting
Ipswich, England, United Kingdom, IP4 5PD
Contact: Contact Person     Not Available        
Leeds Cancer Centre at St. James's University Hospital Recruiting
Leeds, England, United Kingdom, LS9 7TF
Contact: Contact Person     Not Available        
Aintree University Hospital Recruiting
Liverpool, England, United Kingdom, L9 7AL
Contact: Contact Person     44-845-226-3000        
Royal Liverpool University Hospital Recruiting
Liverpool, England, United Kingdom, L7 8XP
Contact: Contact Person     Not Available        
Barts and the London School of Medicine Recruiting
London, England, United Kingdom, EC1M 6BQ
Contact: Contact Person     Not Available        
Christie Hospital Recruiting
Manchester, England, United Kingdom, M20 4BX
Contact: Contact Person     Not Available        
Clatterbridge Centre for Oncology Recruiting
Merseyside, England, United Kingdom, CH63 4JY
Contact: Contact Person     Not Available        
Cancer Research Centre at Weston Park Hospital Recruiting
Sheffield, England, United Kingdom, S1O 2SJ
Contact: Contact Person     Not Available        
Great Western Hospital Recruiting
Swindon, England, United Kingdom, SN3 6BB
Contact: Contact Person     Not Available        
Southend University Hospital NHS Foundation Trust Recruiting
Westcliff-On-Sea, England, United Kingdom, SS0 0RY
Contact: Contact Person     Not Available        
Cancer Care Centre at York Hospital Recruiting
York, England, United Kingdom, Y031 8HE
Contact: Contact Person     Not Available        
Dumfries & Galloway Royal Infirmary Recruiting
Dumfries, Scotland, United Kingdom, DG1 4AP
Contact: Contact Person     Not Available        
Ninewells Hospital Recruiting
Dundee, Scotland, United Kingdom, DD1 9SY
Contact: Contact Person     Not Available        
Edinburgh Cancer Centre at Western General Hospital Recruiting
Edinburgh, Scotland, United Kingdom, EH4 2XU
Contact: Contact Person     Not Available        
Falkirk and District Royal Infirmary Recruiting
Falkirk, Scotland, United Kingdom, FK1 5QE
Contact: Contact Person     Not Available        
Beatson West of Scotland Cancer Centre Recruiting
Glasgow, Scotland, United Kingdom, G12 0YN
Contact: Contact Person     44-141-301-7127     peter.canney@northglasgow.scot.nhs.uk    
Crosshouse Hospital Recruiting
Kilmarnock, Scotland, United Kingdom, KA2 OBE
Contact: Contact Person     Not Available        
Wishaw General Hospital Recruiting
Wishaw, Scotland, United Kingdom, ML2 0DP
Contact: Contact Person     Not Available        
Sponsors and Collaborators
Anglo Celtic Cooperative Oncology Group
Investigators
Principal Investigator: Peter A. Canney, MD University of Glasgow
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00639366     History of Changes
Other Study ID Numbers: CDR0000588868, ACCOG-HER-PCI, ISRCTN64624715, EU-20822
Study First Received: March 19, 2008
Last Updated: December 3, 2009
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
recurrent breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Trastuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013