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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00639366
First received: March 19, 2008
Last updated: August 6, 2013
Last verified: December 2008
  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:


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
Study Completion Date: October 2010
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00639366     History of Changes
Other Study ID Numbers: ACCOG-HER-PCI, CDR0000588868, ISRCTN64624715, EU-20822
Study First Received: March 19, 2008
Last Updated: August 6, 2013
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 August 28, 2014