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

August 6, 2013 updated by: Anglo Celtic Cooperative Oncology Group

Prospective Randomised Clinical Trial Testing the Role of Prophylactic Cranial Radiotherapy in Patients Treated With Trastuzumab (Herceptin®) for Metastatic Breast Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

390

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • England
      • Basildon, England, United Kingdom, SS16 5NL
        • Basildon University Hospital
      • Ipswich, England, United Kingdom, IP4 5PD
        • Ipswich Hospital
      • Leeds, England, United Kingdom, LS9 7TF
        • Leeds Cancer Centre at St. James's University Hospital
      • Liverpool, England, United Kingdom, L9 7AL
        • Aintree University Hospital
      • Liverpool, England, United Kingdom, L7 8XP
        • Royal Liverpool University Hospital
      • London, England, United Kingdom, EC1M 6BQ
        • Barts and the London School of Medicine
      • Manchester, England, United Kingdom, M20 4BX
        • Christie Hospital
      • Merseyside, England, United Kingdom, CH63 4JY
        • Clatterbridge Centre for Oncology
      • Sheffield, England, United Kingdom, S1O 2SJ
        • Cancer Research Centre at Weston Park Hospital
      • Swindon, England, United Kingdom, SN3 6BB
        • Great Western Hospital
      • Westcliff-On-Sea, England, United Kingdom, SS0 0RY
        • Southend University Hospital NHS Foundation Trust
      • York, England, United Kingdom, Y031 8HE
        • Cancer Care Centre at York Hospital
    • Scotland
      • Dumfries, Scotland, United Kingdom, DG1 4AP
        • Dumfries & Galloway Royal Infirmary
      • Dundee, Scotland, United Kingdom, DD1 9SY
        • Ninewells Hospital
      • Edinburgh, Scotland, United Kingdom, EH4 2XU
        • Edinburgh Cancer Centre at Western General Hospital
      • Falkirk, Scotland, United Kingdom, FK1 5QE
        • Falkirk and District Royal Infirmary
      • Glasgow, Scotland, United Kingdom, G12 0YN
        • Beatson West of Scotland Cancer Centre
      • Kilmarnock, Scotland, United Kingdom, KA2 OBE
        • Crosshouse Hospital
      • Wishaw, Scotland, United Kingdom, ML2 0DP
        • Wishaw General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Incidence of symptomatic brain metastases

Secondary Outcome Measures

Outcome Measure
Survival
Cerebral toxicity and quality of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anglo Celtic Cooperative Oncology Group

Investigators

  • Principal Investigator: Peter A. Canney, MD, University of Glasgow

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2007

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

March 19, 2008

First Submitted That Met QC Criteria

March 19, 2008

First Posted (Estimate)

March 20, 2008

Study Record Updates

Last Update Posted (Estimate)

August 7, 2013

Last Update Submitted That Met QC Criteria

August 6, 2013

Last Verified

December 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACCOG-HER-PCI
  • CDR0000588868 (Registry Identifier: PDQ (Physician Data Query))
  • ISRCTN64624715
  • EU-20822

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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