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

NCT00639366 | Completed Phase 3

• 4 other identifiers: ACCOG-HER-PCICDR0000588868ISRCTN64624715EU-20822
• Study Type: interventional
• Target: 390
• Locations: 1 country
• Sites: 19

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.

Conditions

Breast Cancer

Keywords

recurrent breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; stage IV breast cancer

Outcome Measures

Primary Outcomes (1)

• Incidence of symptomatic brain metastases

Secondary Outcomes (2)

• Survival

• Cerebral toxicity and quality of life

Interventions

trastuzumab BIOLOGICAL

chemotherapy DRUG

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Anglo Celtic Cooperative Oncology Group: lead

Study Sites (19)

Basildon University Hospital

Basildon, England, SS16 5NL, United Kingdom

Location

Ipswich Hospital

Ipswich, England, IP4 5PD, United Kingdom

Location

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

Royal Liverpool University Hospital

Liverpool, England, L7 8XP, United Kingdom

Location

Aintree University Hospital

Liverpool, England, L9 7AL, United Kingdom

Location

Barts and the London School of Medicine

London, England, EC1M 6BQ, United Kingdom

Location

Christie Hospital

Manchester, England, M20 4BX, United Kingdom

Location

Clatterbridge Centre for Oncology

Merseyside, England, CH63 4JY, United Kingdom

Location

Cancer Research Centre at Weston Park Hospital

Sheffield, England, S1O 2SJ, United Kingdom

Location

Great Western Hospital

Swindon, England, SN3 6BB, United Kingdom

Location

Southend University Hospital NHS Foundation Trust

Westcliff-on-Sea, England, SS0 0RY, United Kingdom

Location

Cancer Care Centre at York Hospital

York, England, Y031 8HE, United Kingdom

Location

Dumfries & Galloway Royal Infirmary

Dumfries, Scotland, DG1 4AP, United Kingdom

Location

Ninewells Hospital

Dundee, Scotland, DD1 9SY, United Kingdom

Location

Edinburgh Cancer Centre at Western General Hospital

Edinburgh, Scotland, EH4 2XU, United Kingdom

Location

Falkirk and District Royal Infirmary

Falkirk, Scotland, FK1 5QE, United Kingdom

Location

Beatson West of Scotland Cancer Centre

Glasgow, Scotland, G12 0YN, United Kingdom

Location

Crosshouse Hospital

Kilmarnock, Scotland, KA2 OBE, United Kingdom

Location

Wishaw General Hospital

Wishaw, Scotland, ML2 0DP, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Trastuzumab; Drug Therapy; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Therapeutics

Study Officials

• Peter A. Canney, MD

  University of Glasgow

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: PREVENTION
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 19, 2008
• First Posted: March 20, 2008
• Study Start: February 1, 2007
• Primary Completion: February 1, 2010
• Study Completion: October 1, 2010
• Last Updated: August 7, 2013

Record last verified: 2008-12

Locations

GB (19)