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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

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ClinicalTrials.gov Identifier: NCT00639366
Recruitment Status : Completed
First Posted : March 20, 2008
Last Update Posted : August 7, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE March 19, 2008
First Posted Date  ICMJE March 20, 2008
Last Update Posted Date August 7, 2013
Study Start Date  ICMJE February 2007
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 19, 2008)
Incidence of symptomatic brain metastases
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00639366 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2008)
  • Survival
  • Cerebral toxicity and quality of life
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Radiation Therapy to the Head in Preventing Brain Metastases in Women Receiving Trastuzumab and Chemotherapy for Metastatic or Locally Advanced Breast Cancer
Official Title  ICMJE Prospective Randomised Clinical Trial Testing the Role of Prophylactic Cranial Radiotherapy in Patients Treated With Trastuzumab (Herceptin®) for Metastatic Breast Cancer
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Primary Purpose: Prevention
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Biological: trastuzumab
  • Drug: chemotherapy
  • Radiation: radiation therapy
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: March 19, 2008)
390
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2010
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00639366
Other Study ID Numbers  ICMJE ACCOG-HER-PCI
CDR0000588868 ( Registry Identifier: PDQ (Physician Data Query) )
ISRCTN64624715
EU-20822
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Anglo Celtic Cooperative Oncology Group
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Peter A. Canney, MD University of Glasgow
PRS Account National Cancer Institute (NCI)
Verification Date December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP