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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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
trastuzumab
chemotherapy
radiation therapy
Sponsored by
Anglo Celtic Cooperative Oncology Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer focused on measuring recurrent breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Basildon University Hospital
  • Ipswich Hospital
  • Leeds Cancer Centre at St. James's University Hospital
  • Royal Liverpool University Hospital
  • Aintree University Hospital
  • Barts and the London School of Medicine
  • Christie Hospital
  • Clatterbridge Centre for Oncology
  • Cancer Research Centre at Weston Park Hospital
  • Great Western Hospital
  • Southend University Hospital NHS Foundation Trust
  • Cancer Care Centre at York Hospital
  • Dumfries & Galloway Royal Infirmary
  • Ninewells Hospital
  • Edinburgh Cancer Centre at Western General Hospital
  • Falkirk and District Royal Infirmary
  • Beatson West of Scotland Cancer Centre
  • Crosshouse Hospital
  • Wishaw General Hospital

Outcomes

Primary Outcome Measures

Incidence of symptomatic brain metastases

Secondary Outcome Measures

Survival
Cerebral toxicity and quality of life

Full Information

First Posted
March 19, 2008
Last Updated
August 6, 2013
Sponsor
Anglo Celtic Cooperative Oncology Group
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1. Study Identification

Unique Protocol Identification Number
NCT00639366
Brief Title
Radiation Therapy to the Head in Preventing Brain Metastases in Women Receiving Trastuzumab and Chemotherapy for Metastatic or Locally Advanced Breast Cancer
Official Title
Prospective Randomised Clinical Trial Testing the Role of Prophylactic Cranial Radiotherapy in Patients Treated With Trastuzumab (Herceptin®) for Metastatic Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Anglo Celtic Cooperative Oncology Group

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
recurrent breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Allocation
Randomized
Enrollment
390 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
trastuzumab
Intervention Type
Drug
Intervention Name(s)
chemotherapy
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Incidence of symptomatic brain metastases
Secondary Outcome Measure Information:
Title
Survival
Title
Cerebral toxicity and quality of life

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter A. Canney, MD
Organizational Affiliation
University of Glasgow
Official's Role
Principal Investigator
Facility Information:
Facility Name
Basildon University Hospital
City
Basildon
State/Province
England
ZIP/Postal Code
SS16 5NL
Country
United Kingdom
Facility Name
Ipswich Hospital
City
Ipswich
State/Province
England
ZIP/Postal Code
IP4 5PD
Country
United Kingdom
Facility Name
Leeds Cancer Centre at St. James's University Hospital
City
Leeds
State/Province
England
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Royal Liverpool University Hospital
City
Liverpool
State/Province
England
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
Aintree University Hospital
City
Liverpool
State/Province
England
ZIP/Postal Code
L9 7AL
Country
United Kingdom
Facility Name
Barts and the London School of Medicine
City
London
State/Province
England
ZIP/Postal Code
EC1M 6BQ
Country
United Kingdom
Facility Name
Christie Hospital
City
Manchester
State/Province
England
ZIP/Postal Code
M20 4BX
Country
United Kingdom
Facility Name
Clatterbridge Centre for Oncology
City
Merseyside
State/Province
England
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
Facility Name
Cancer Research Centre at Weston Park Hospital
City
Sheffield
State/Province
England
ZIP/Postal Code
S1O 2SJ
Country
United Kingdom
Facility Name
Great Western Hospital
City
Swindon
State/Province
England
ZIP/Postal Code
SN3 6BB
Country
United Kingdom
Facility Name
Southend University Hospital NHS Foundation Trust
City
Westcliff-On-Sea
State/Province
England
ZIP/Postal Code
SS0 0RY
Country
United Kingdom
Facility Name
Cancer Care Centre at York Hospital
City
York
State/Province
England
ZIP/Postal Code
Y031 8HE
Country
United Kingdom
Facility Name
Dumfries & Galloway Royal Infirmary
City
Dumfries
State/Province
Scotland
ZIP/Postal Code
DG1 4AP
Country
United Kingdom
Facility Name
Ninewells Hospital
City
Dundee
State/Province
Scotland
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Edinburgh Cancer Centre at Western General Hospital
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Falkirk and District Royal Infirmary
City
Falkirk
State/Province
Scotland
ZIP/Postal Code
FK1 5QE
Country
United Kingdom
Facility Name
Beatson West of Scotland Cancer Centre
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G12 0YN
Country
United Kingdom
Facility Name
Crosshouse Hospital
City
Kilmarnock
State/Province
Scotland
ZIP/Postal Code
KA2 OBE
Country
United Kingdom
Facility Name
Wishaw General Hospital
City
Wishaw
State/Province
Scotland
ZIP/Postal Code
ML2 0DP
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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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