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

Phase 3

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00639366
• Lead Sponsor: Anglo Celtic Cooperative Oncology Group

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 Timeline

• Study Start: 2007-02
• Study First Submitted: 2008-03-19
• Study First Submitted QC: 2008-03-19
• Study First Posted: 2008-03-20
• Status Verified: 2008-12
• Primary Completion: 2010-02
• Study Completion: 2010-10
• Last Update Submitted: 2013-08-06
• Last Update Posted: 2013-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 390

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of symptomatic brain metastases

Secondary Outcome Measures

Name	Time	Method
Survival
Cerebral toxicity and quality of life

Trial Locations

Locations (19)

Basildon University Hospital; 🇬🇧 Basildon, England, United Kingdom

Ipswich Hospital; 🇬🇧 Ipswich, England, United Kingdom

Leeds Cancer Centre at St. James's University Hospital; 🇬🇧 Leeds, England, United Kingdom

Royal Liverpool University Hospital; 🇬🇧 Liverpool, England, United Kingdom

Aintree University Hospital; 🇬🇧 Liverpool, England, United Kingdom

Barts and the London School of Medicine; 🇬🇧 London, England, United Kingdom

Christie Hospital; 🇬🇧 Manchester, England, United Kingdom

Clatterbridge Centre for Oncology; 🇬🇧 Merseyside, England, United Kingdom

Cancer Research Centre at Weston Park Hospital; 🇬🇧 Sheffield, England, United Kingdom

Great Western Hospital; 🇬🇧 Swindon, England, United Kingdom

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