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Study record managers: refer to the Data Element Definitions if submitting registration or information. Hormone therapy using triptorelin, exemestane, and tamoxifen may fight breast cancer by blocking the use of estrogen. It is not yet known whether giving triptorelin together with exemestane is more effective than triptorelin and tamoxifen in treating hormone-responsive breast cancer. PURPOSE: This randomized phase III trial is studying triptorelin and exemestane to see how well they work compared to triptorelin and tamoxifen in treating premenopausal women with hormone-responsive breast cancer.

Patients are stratified according to planned use of concurrent adjuvant chemotherapy yes vs noand of positive lymph nodes 0 vs 1 or more. Treatment duration is 5 years.

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Patients are followed every 3 months for 1 year, every 6 months for 5 years, and then annually thereafter. Quality of life is assessed at baseline, every 6 months for 2 years, and annually for 3 years. Tamoxifen T begins after the completion of adjuvant chemotherapy if given, or approximately weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.

Exemestane E begins after the completion of adjuvant chemotherapy if given, or approximately weeks after the initiation of triptorelin. Drug: exemestane Other Name: Aromasin Drug: triptorelin Other Names: GnRH analogue Trelstar Depot Decapeptyl Depot Outcome Measures Go to Top of Study Description Study De Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information Primary Outcome Measures : Disease-free Survival [ Time Frame: 5-year estimate reported at a median follow-up of 72 months ] Estimated percentage of patients alive and disease-free at 5 years from randomization, where disease-free survival is defined as the time from randomization to the first appearance of one of the following: invasive breast cancer recurrence at local, regional, or distant site, invasive contralateral breast cancer, second non-breast invasive cancer, or death without cancer event; or censored at date of last follow up.

Secondary Outcome Measures : Breast Cancer-free Interval [ Time Frame: 5-year estimate reported at a median follow-up of 72 months ] Estimated percentage of patients alive and disease-free at 5 years from randomization, where breast Better Adult Dating - older women in wilkes Slovenia interval is defined as the time from randomization to the invasive breast cancer recurrence at local, regional, or distant site, or invasive contralateral breast cancer; or censored at date of last follow up. Distant Recurrence-free Interval [ Time Frame: 5-year estimates reported at a median follow-up of 72 months ] Estimated percentage of patients alive and disease-free at 5 years from randomization, where distant recurrence-free interval is defined as the time from randomization to breast cancer recurrence at a distant site; or censored at date of last follow-up Overall Survival [ Time Frame: 8-year estimates, reported at a median follow-up of 9 years ] Estimated percentage of patients alive at 8 years from randomization, where overall survival is defined as the time from randomization to death from any cause; or censored at date last known alive.

Talk with your doctor and family members or friends about deciding to a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. Prior surgery for primary breast cancer of 1 of the following types:.

Axillary lymph node dissection or a negative axillary sentinel node biopsy required. No locally advanced inoperable breast cancer, including any of the following:. Estradiol in the premenopausal range after prior surgery OR meets the following criteria:. No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, nonbreast carcinoma in situ, contralateral or ipsilateral carcinoma in situ of the breast, or other nonrecurrent invasive nonbreast malignancy, including any of the following:.

No concurrent bisphosphonates, except in the following cases:. Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or information. Search for terms x. Save this study.

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Warning You have reached the maximum of saved studies Listing a study does not mean it has been evaluated by the U. Federal Government. Read our disclaimer for details. First Posted : April 5, Last Update Posted : March 11, Study Description. Detailed Description:.

Compare the quality of life, including late side effects of early menopause, of patients treated with these regimens. MedlinePlus related topics: Breast Cancer. FDA Resources. Arms and Interventions. Outcome Measures. Primary Outcome Measures : Disease-free Survival [ Time Frame: 5-year estimate reported at a median follow-up of 72 months ] Estimated percentage of patients alive and disease-free at 5 years from randomization, where disease-free survival is defined as the time from randomization to the first appearance of one of the following: invasive breast cancer recurrence at local, regional, or distant site, invasive contralateral breast cancer, second non-breast invasive cancer, or death without cancer event; or censored at date of last follow up.

Estimated percentage of patients alive and disease-free at 5 years from randomization, where distant recurrence-free interval is defined as the time from randomization to breast cancer recurrence at a distant site; or censored at date of last follow-up. Estimated percentage of patients alive at 8 years from randomization, where overall survival is defined as the time from randomization to death from any cause; or censored at date last known alive. Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Contacts and Locations.

Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials. Gallen St. More Information. Adjuvant exemestane with ovarian suppression in premenopausal breast cancer. N Engl J Med. Epub Jun 1.

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Premenopausal endocrine-responsive early breast cancer: who receives chemotherapy? Ann Oncol.

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Epub Mar 5. Death due to liver failure during endocrine therapy for premenopausal breast cancer. Acta Oncol. Epub Oct 2. J Clin Oncol. Epub Oct Epub Jun 4. Concurrent and sequential initiation of ovarian function suppression with chemotherapy in premenopausal women with endocrine-responsive early breast cancer: an exploratory analysis of TEXT and SOFT.

Breast Cancer Res. Epub Apr 4. Patient-reported outcomes with adjuvant exemestane versus tamoxifen in premenopausal women with early breast cancer undergoing ovarian suppression TEXT and SOFT : a combined analysis of two phase 3 randomised trials. Lancet Oncol. Epub Jun National Library of Medicine U. National Institutes of Health U. Department of Health and Human Services. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.

Breast Cancer. Drug: exemestane Drug: tamoxifen Drug: triptorelin. Phase 3. Study Type :. Interventional Clinical Trial. Actual Enrollment :. Study Start Date :. Actual Primary Completion Date :. Estimated Study Completion Date :. Mission Hills, California, United States, Ruby L.

Better Adult Dating - older women in wilkes Slovenia

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