NCT06223698

Optimizing Extended Adjuvant Endocrine Therapy in Patients With Breast Cancer

Optimizing Extended Adjuvant Endocrine Therapy in Patients With Breast Cancer: a Registry-based Randomized Clinical Trial - SWE-Switch Breast Cancer Trial

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,832 (estimated)
• Sponsor: Region Örebro County · Academic / Other
• Sex: Female
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-05-02
• Primary completion: 2032-05-02
• Completion: 2035-05-02
• First posted: 2024-01-25
• Last updated: 2025-04-20

Locations

15 sites across 1 country: Sweden