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NOT YET RECRUITING
NCT06223698
PHASE3

Optimizing Extended Adjuvant Endocrine Therapy in Patients With Breast Cancer

Sponsor: Region Örebro County

View on ClinicalTrials.gov

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

DRUG

Letrozole

Letrozole 2.5 mg daily

DRUG

Anastrozole

Anastrozole 1 mg daily

DRUG

Exemestane

Exemestane 25 mg daily

DRUG

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