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RECRUITING
NCT05297617
PHASE2

Deescalation of Endocrine Therapy Duration in Women With HR+ HER2- Breast Cancer at Very Low Risk

Sponsor: UNICANCER

View on ClinicalTrials.gov

Summary

Hormone therapy is recommended for five years in all patients with hormone receptor-positive breast cancer, but there is no consensus on its duration in low-risk tumours and especially in postmenopausal women. Adjuvant endocrine therapy (ET) is associated with substantial side effects and long-term decreased quality of life. Moreover, while it has been shown that ET provides a real benefit in reducing the relapse rate over time, the deterioration in quality of life may also have a negative effect on patient adherence to treatment. It is therefore important to offer treatment to women with low-risk cancer less intensive treatment strategies. If recent trials tested longer durations as compared to 5 years for high-risk cancers, older trials have tested shorter durations. The 5-year duration appeared at that time as the gold standard because of optimal benefit-risk ratios of tamoxifen among high-risk patients. However shorter treatments of 2-3 years were already associated with substantial benefits and may be enough for very low risk patients.

Official title: Single-arm Study to De-escalate Adjuvant Endocrine Therapy Duration in Women With HR+ HER2- Breast Cancer at Very Low Risk of Metastasis

Key Details

Gender

FEMALE

Age Range

51 Years - Any

Study Type

INTERVENTIONAL

Enrollment

696

Start Date

2022-10-12

Completion Date

2035-11

Last Updated

2025-03-30

Healthy Volunteers

No

Conditions

Interventions

DRUG

Anti-aromatase inhibitor

Treatment will be either: * Letrozole, given per os, 2.5 mg daily * Anastrozole, given per os, 1 mg daily * Exemestane, given per os, 25 mg daily

Locations (2)

Centre Hospitalier Universitaire de Limoges

Limoges, France

Institute Gustave Roussy

Villejuif, France