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Optimizing Extended Adjuvant Endocrine Therapy in Patients With Breast Cancer

NCT06223698 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3832

Last updated 2025-04-20

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Mid-Sweden Regional Cancer Centre

    collaborator UNKNOWN

  • Akademiska University Hospital, Uppsala, Sweden

    collaborator UNKNOWN

  • Region Örebro County

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-02
Primary Completion
2032-05-02
Completion
2035-05-02

Countries

  • Sweden

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06223698 on ClinicalTrials.gov