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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Randomized Study of Prophylactic Cranial Radiotherapy in Women With Metastatic or Locally Advanced Breast Cancer Previously Treated With Trastuzumab (Herceptin®) and Taxane Chemotherapy

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Prevention, Treatment Active 18 and over Other ACCOG-HER-PCI ACCOG-HER-PCI, ISRCTN64624715, EU-20822, NCT00639366

Trial Description

Purpose:

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.

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.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• No brain metastases or CNS disease
• No previous radiation therapy to the head
• No previous surgery involving the brain or nervous system
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be randomly assigned (have an equal chance of being placed) to one of two treatment groups.

Patients in group one will receive paclitaxel or docetaxel and trastuzumab for 6 weeks. They will also undergo radiation therapy to the head for up to 10 treatments while still receiving chemotherapy and trastuzumab.

Patients in group two will receive paclitaxel or docetaxel and trastuzumab.

Quality of life will be assessed every 8 weeks for 9 months. After finishing treatment, patients will be evaluated periodically for at least 1 year.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

Anglo Celtic Cooperative Oncology Group

Peter Canney, MD, Principal investigator		Ph: 44-141-211-1743 Email: peter.canney.wg@northglasgow.scot.nhs.uk

United Kingdom
Scotland
	Glasgow
	Beatson West of Scotland Cancer Centre
		Contact Person	Ph:  44-141-301-7127
			Email: peter.canney@northglasgow.scot.nhs.uk

Registry Information
Official Title		Prospective randomised clinical trial testing the role of prophylactic cranial radiotherapy in patients treated with Trastuzumab (Herceptin®) for metastatic breast cancer
Trial Start Date		2007-02-03
Trial Completion Date		2010-02-03 (estimated)
Registered in ClinicalTrials.gov		NCT00639366
Date Submitted to PDQ		2008-02-27
Information Last Verified		2008-04-20