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Skipping Hormone Therapy in Low-Risk Early Breast Cancer

NCT07661927 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 700

Last updated 2026-07-17

No results posted yet for this study

Summary

The goal of this clinical trial is to determine whether a selected population of women with early-stage, low-risk breast cancer can avoid hormone therapy without increasing their risk of relapse. It will also evaluate the prognosis of these participants compared to participants who received standard treatment with hormone therapy in another study, estimate the risk of specific recurrence, cardiovascular and bone health, and participants' quality of life.

All participants will have undergone surgery and possibly radiation therapy, but unlike standard care, they will not receive hormone therapy afterward. Participants will be enrolled for two years and followed for up to five years after the last participant is enrolled in the trial to monitor for long-term cancer recurrence.

Conditions

  • Breast Cancer (Early Breast Cancer)

Interventions

DRUG

Removing Endocrine Therapy

The standard of care endocrine therapy (Tamoxifene, Letrozole, Anastrozole or Exemestane) will not be received by the participant during the study.

Sponsors & Collaborators

  • Swiss Cancer Institute

    collaborator OTHER

  • UNICANCER

    lead OTHER

Principal Investigators

  • Jean-Yves PIERGA, MD · Institut Curie

  • José Luis SANDOVAL, MD · University Hospital, Geneva

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-06
Primary Completion
2033-07-06
Completion
2033-07-06

Countries

  • France

Study Locations

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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 NCT07661927 on ClinicalTrials.gov