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.
First Published: 4/1/1999  Last Modified: 8/18/2009
Hormone Replacement Therapy and the Risk of Breast Cancer Recurrence in Women With Previous Early Stage 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
A total of 1,300 patients will be accrued for this study within 5-6 years.
This is a randomized, open-label, multicenter study. Patients are stratified by center, prior hormone replacement therapy before diagnosis, and concurrent tamoxifen therapy. Patients are randomized to one of two treatment arms.
Treatment in both arms continues for 2 years in the absence of disease progression. Patients may continue their randomized treatment regimen at the discretion of the treating physician.
Quality of life is assessed 3 times during the study and then every two years thereafter. Gynecological health is assessed at 3 months, 6 months, and one year during the study and then annually for at least 5 years. Breast cancer is assessed every 6 months for 3 years and then annually thereafter or at the discretion of the treating physician.
Holmberg L, Iversen OE, Rudenstam CM, et al.: Increased risk of recurrence after hormone replacement therapy in breast cancer survivors. J Natl Cancer Inst 100 (7): 475-82, 2008.[PUBMED Abstract]
Holmberg L, Anderson H; HABITS steering and data monitoring committees: HABITS (hormonal replacement therapy after breast cancer--is it safe?), a randomised comparison: trial stopped. Lancet 363 (9407): 453-5, 2004.[PUBMED Abstract]
Brincat M, Muscat Baron Y, Ciantar E: Hormone replacement in women with breast cancer: the HABITS study. Endocrine 24 (3): 255-7, 2004.[PUBMED Abstract]
Trial Contact Information
Trial Lead Organizations
Regional Oncologic Center
Lars Holmberg, MD, PhD, Protocol chair
Scandinavian Breast Group
Jonas Bergh, MD, PhD, Protocol chair
International Breast Cancer Study Group
C. Rageth, MD, PD, Protocol chair
European Organization for Research and Treatment of Cancer
Janusz Jaskiewicz, MD, Protocol chair
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.