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

Alternate Title

Phase III Randomized Study of Hormone Replacement Therapy in Menopausal or Perimenopausal Women With Prior Stage 0-II Breast Cancer. Note: The information about this trial has not been updated by the sponsor/principal investigator/lead organization. Cancer.gov cannot verify the accuracy of the information.

Basic Trial Information

Trial Description

Purpose:

Hormone replacement therapy is effective for relieving symptoms of menopause. It is not yet known if hormone replacement therapy increases the risk of breast cancer recurrence in women previously treated for early stage breast cancer.

Randomized phase III trial to determine the risk of breast cancer recurrence in women with previous early stage breast cancer who are receiving hormone replacement therapy for menopause symptoms.

Eligibility:

• Menopausal or perimenopausal
• No evidence of breast cancer
• No hormone replacement therapy begun after breast cancer diagnosis
• Not receiving hormone therapy other than tamoxifen or toremifene
• 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 to either receive daily hormone replacement therapy by mouth or nonhormonal therapy, such as drug therapy, counseling, exercise, or acupuncture. Treatment may continue for as long as benefit is shown. Quality of life will be assessed three times during the study and every 2 years thereafter. Patients will be evaluated at 3 and 6 months, every 6 months until year 3, and once a year thereafter.

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

Regional Oncologic Center

Lars Holmberg, MD, PhD, Protocol chair		Ph: 46-18-151-910 Email: Lars.Holmberg@akademiska.se

Scandinavian Breast Group

Jonas Bergh, MD, PhD, Protocol chair		Ph: 46-8-517-762-79

International Breast Cancer Study Group

C. Rageth, MD, PD, Protocol chair		Ph: 41-44-380-76-60 Email: c.rageth@brust-zentrum.ch

European Organization for Research and Treatment of Cancer

Janusz Jaskiewicz, MD, Protocol chair		Ph: 48-22-644-0024

Registry Information
Official Title		Protocol for Randomized Clinical Study Concerning Hormonal Replacement Therapy (HRT) After Previous Radical Breast Cancer Treatment
Trial Start Date		1997-09-17
Registered in ClinicalTrials.gov		NCT00003771
Date Submitted to PDQ		1999-02-05
Information Last Verified		2001-07-06

Back to Top