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Home > "H" Clinical Trials Conditions > Hormone Replacement Therapy and the Risk of Breast Cancer Recurrence in Women With Previous Early Stage Breast Cancer  Hormone Replacement Therapy and the Risk of Breast Cancer Recurrence in Women With Previous Early Stage Breast Cancer
Hormone Replacement Therapy and the Risk of Breast Cancer Recurrence in Women With Previous Early Stage Breast Cancer
For Condition: breast cancer in situ,stage 2 breast cancer,menopausal symptoms,stage 1 breast cancer
Status: No longer recruiting
Sponsor(s): Regional Oncologic Center , Scandinavian Breast Group,International Breast Cancer Study Group,EORTC Breast Cancer Cooperative Group
Synopsis: 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: Randomizedphase 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.
Details: OBJECTIVES: - Evaluate the safety of hormone replacement therapy, in terms of risk of recurrence, in women with previously treated, nonrecurrent stage 0-II breast cancer. - Compare this regimen vs non-hormonal symptomatic treatment, in terms of quality of life and risk of death, in this patient population. 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. - Arm I: Patients receive one of the following: Women with an intact uterus whose last menstrual bleeding has occurred within 2 years receive continuous oral cyclic estradiol-norethindrone combination comprising estradiol only on days 1-12, estradiol plus norethindrone on days 13-22, and then estradiol only on days 22-28. Women with an intact uterus whose last menstrual bleeding occurred more than 2 years prior to study receive continuous daily oral estradiol-norethindrone combination. Women who have had a hysterectomy receive continuous daily oral estradiol only. - Arm II: Patients receive one or more non-hormonal therapies (e.g., clonidine, beta blockers, psychological support, physical exercise, acupuncture). 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. PROJECTED ACCRUAL: A total of 1,300 patients will be accrued for this study within 5-6 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - History of stage 0-II breast cancer with no more than 4 involved axillary nodes if nodal status and number of nodes investigated is known - No current evidence of disease - Hormone receptor status: - Positive, negative, or unknown PATIENT CHARACTERISTICS: Age: - Not specified Sex: - Female Menopausal status: - Menopausal or perimenopausal Performance status: - Not specified Life expectancy: - Not specified Hematopoietic: - Not specified Hepatic: - No active liver disease Renal: - Not specified Cardiovascular: - No prior or concurrent deep vein thrombosis - No hereditary traits for deep vein thrombosis - No prior or concurrent cerebral stroke - No prior or concurrent coronary disease Other: - No prior malignancy except basal cell skin cancer or carcinoma in situ of the cervix - No porphyria - No other serious disease that would prevent compliance or greatly limit life expectancy PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No concurrent chemotherapy Endocrine therapy: - Prior hormone replacement therapy (HRT) allowed if stopped no more than 4 weeks after breast cancer diagnosis and at least 3 months prior to study - No prior HRT initiated after breast cancer diagnosis - No concurrent hormonal therapy for breast cancer except tamoxifen or toremifene Radiotherapy: - No concurrent radiotherapy Surgery: - Not specified Other: - No prior randomization into trials comparing effects of chemotherapy and bilateral oophorectomy in premenopausal women
Total Enrollment:
Location and Contact Information:
Overall Study Official:
LarsHolmberg, Study Chair, Uppsala University Hospital
Norwegian Radium Hospital
Oslo, , N-0310
Norway
Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
Warsaw, , 02-781
Poland
Karolinska Hospital
Stockholm, , S-171 76
Sweden
Helsinki University Central Hospital
Helsinki, , FIN-00029
Finland
Breast Center
Zurich, , CH-8008
Switzerland
Uppsala University Hospital
Uppsala, , S-75185
Sweden
Additional Information:
Study ID Numbers: CDR0000066897; ROC-HABITS,EORTC-10992,IBCSG-17-98,SBG-HABITS,EU-98077
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003771
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Hormone Replacement Therapy and the Risk of Breast Cancer Recurrence in Women With Previous Early Stage Breast Cancer
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