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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)

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.


Condition or disease Intervention/treatment Phase
Breast Cancer Biological: trastuzumab Drug: chemotherapy Radiation: radiation therapy Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 390 participants
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
Study Start Date : February 2007
Actual Primary Completion Date : February 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Trastuzumab




Primary Outcome Measures :
  1. Incidence of symptomatic brain metastases

Secondary Outcome Measures :
  1. Survival
  2. Cerebral toxicity and quality of life


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00639366


Locations
Show Show 19 study locations
Sponsors and Collaborators
Anglo Celtic Cooperative Oncology Group
Investigators
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Principal Investigator: Peter A. Canney, MD University of Glasgow
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ClinicalTrials.gov Identifier: NCT00639366    
Other Study ID Numbers: ACCOG-HER-PCI
CDR0000588868 ( Registry Identifier: PDQ (Physician Data Query) )
ISRCTN64624715
EU-20822
First Posted: March 20, 2008    Key Record Dates
Last Update Posted: August 7, 2013
Last Verified: December 2008
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:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents