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Optimizing Extended Adjuvant Endocrine Therapy in Patients With Breast Cancer
Sponsor: Region Örebro County
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.
Official title: Optimizing Extended Adjuvant Endocrine Therapy in Patients With Breast Cancer: a Registry-based Randomized Clinical Trial - SWE-Switch Breast Cancer Trial
Key Details
Gender
FEMALE
Age Range
18 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
3832
Start Date
2025-05-02
Completion Date
2035-05-02
Last Updated
2025-04-20
Healthy Volunteers
No
Conditions
Interventions
Letrozole
Letrozole 2.5 mg daily
Anastrozole
Anastrozole 1 mg daily
Exemestane
Exemestane 25 mg daily
Tamoxifen
Tamoxifen 20 mg daily
Locations (15)
Visby Hospital
Visby, Gotland County, Sweden
General Hospital of Eskilstuna
Eskilstuna, Sweden
Falun County Hospital
Falun, Sweden
Gävle Hospital
Gävle, Sweden
Sahlgrenska University Hospital
Gothenburg, Sweden
Ryhov County Hospital
Jönköping, Sweden
Kalmar Hospital
Kalmar, Sweden
Lund University Hospital
Lund, Sweden
Örebro University Hospital
Örebro, Sweden
Karolinska University Hospital
Stockholm, Sweden
St Göran Capio Hospital
Stockholm, Sweden
University Hospital of Umeå
Umeå, Sweden
Akademiska University Hospital Uppsala
Uppsala, Sweden
Växjö Hospital
Vaxjo, Sweden
Västerås General Hospital
Västerås, Sweden