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

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Anglo Celtic Cooperative Oncology Group
• Treatments: Trastuzumab

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