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Sponsors and Collaborators: |
Regional Oncologic Center Scandinavian Breast Group International Breast Cancer Study Group European Organization for Research and Treatment of Cancer |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003771 |
RATIONALE: 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.
PURPOSE: 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.
Condition | Intervention | Phase |
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Breast Cancer Menopausal Symptoms |
Biological: therapeutic estradiol Drug: norethindrone acetate |
Phase III |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Open Label, Active Control |
Official Title: | Protocol for Randomized Clinical Study Concerning Hormonal Replacement Therapy (HRT) After Previous Radical Breast Cancer Treatment |
Estimated Enrollment: | 1300 |
Study Start Date: | September 1997 |
OBJECTIVES:
OUTLINE: 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.
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.
PROJECTED ACCRUAL: A total of 1,300 patients will be accrued for this study within 5-6 years.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Finland | |
Helsinki University Central Hospital | |
Helsinki, Finland, FIN-00029 | |
Norway | |
Norwegian Radium Hospital | |
Oslo, Norway, N-0310 | |
Poland | |
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology | |
Warsaw, Poland, 02-781 | |
Sweden | |
Karolinska Hospital | |
Stockholm, Sweden, S-171 76 | |
Uppsala University Hospital | |
Uppsala, Sweden, S-75185 | |
Switzerland | |
Breast Center | |
Zurich, Switzerland, CH-8008 |
Study Chair: | Lars Holmberg, MD, PhD | Uppsala University Hospital |
Study Chair: | Jonas Bergh, MD, PhD | Karolinska University Hospital - Solna |
Study Chair: | C. Rageth, MD, PD | Breast Center |
Study Chair: | Janusz Jaskiewicz, MD | Maria Sklodowska-Curie Memorial Cancer Center, Institute of Oncology |
Study ID Numbers: | CDR0000066897, ROC-HABITS, EORTC-10992, IBCSG-17-98, SBG-HABITS, EU-98077 |
Study First Received: | November 1, 1999 |
Last Updated: | August 19, 2009 |
ClinicalTrials.gov Identifier: | NCT00003771 History of Changes |
Health Authority: | United States: Federal Government |
menopausal symptoms stage I breast cancer stage II breast cancer breast cancer in situ |
Estrogens Skin Diseases Contraceptive Agents Benzoates Hormone Antagonists Contraceptives, Oral Estradiol valerate Contraceptive Agents, Female Hormones, Hormone Substitutes, and Hormone Antagonists Breast Neoplasms |
Estradiol 17 beta-cypionate Hormones Recurrence Estradiol Norethindrone Estradiol 3-benzoate Polyestradiol phosphate Breast Diseases Menopause Norethindrone acetate |
Estrogens Skin Diseases Contraceptive Agents Contraceptives, Oral Physiological Effects of Drugs Estradiol valerate Contraceptive Agents, Female Hormones, Hormone Substitutes, and Hormone Antagonists Breast Neoplasms Reproductive Control Agents Estradiol 17 beta-cypionate Hormones |
Pharmacologic Actions Estradiol Neoplasms Neoplasms by Site Norethindrone Therapeutic Uses Estradiol 3-benzoate Contraceptives, Oral, Synthetic Polyestradiol phosphate Breast Diseases Norethindrone acetate |