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Brief Title: Optimizing Extended Adjuvant Endocrine Therapy in Patients With Breast Cancer
Official Title: Optimizing Extended Adjuvant Endocrine Therapy in Patients With Breast Cancer: a Registry-based Randomized Clinical Trial - SWE-Switch Breast Cancer Trial
Study ID: NCT06223698
Brief Summary: Based on the risk of late recurrence in breast cancer patients with luminal disease with high-risk for recurrence, extended adjuvant endocrine therapy beyond 5 years is recommended as a valid treatment option. In premenopausal women at diagnosis converted to postmenopausal after the first five years of tamoxifen, two treatment strategies for extended adjuvant endocrine therapy are available, namely continuing with tamoxifen or switching to aromatase inhibitors (AI). No randomized evidence does exist and both treatment strategies are used in clinical practice. In postmenopausal women with higher recurrence risk initially treated with AI for five years, extended adjuvant therapy with additional two years of AI has shown to be as effective as additional five years of AI. However, no randomized evidence on whether a switching strategy of five-year extended tamoxifen is better compared to two-year extended AI is available. Both treatment strategies are used in clinical practice. The primary objective of this register-based randomized trial is to investigate the overall survival between patients treated with switching strategy for extended adjuvant endocrine therapy compared to continuing with the same treatment as the initial 5 years in two different clinical scenarios: * In premenopausal women at diagnosis who converted to postmenopausal after 5 years of tamoxifen. * In postmenopausal women at diagnosis.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
General Hospital of Eskilstuna, Eskilstuna, , Sweden
Falun County Hospital, Falun, , Sweden
Sahlgrenska University Hospital, Göteborg, , Sweden
Ryhov County Hospital, Jönköping, , Sweden
Lund University Hospital, Lund, , Sweden
Karolinska University Hospital, Stockholm, , Sweden
University Hospital of Umeå, Umeå, , Sweden
Akademiska University Hospital Uppsala, Uppsala, , Sweden
Västerås General Hospital, Västerås, , Sweden
Örebro University Hospital, Örebro, , Sweden