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Omission of Surgery for Triple-negative Breast Cancer in Complete Response After Neoadjuvant Chemo-immunotherapy

NCT07357948 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2026-01-22

No results posted yet for this study

Summary

This clinical study aims to determine if skipping breast and axillary surgery could provide similar control of local and distant disease, with fewer complications and better quality of life, for triple-negative breast cancer patients in complete response after neoadjuvant chemo-immunotherapy.

Patients will be randomised into 2 groups :

* Control arm will receive the standard treatment, including surgery
* Experimental arm will receive the standard treatment, except surgery

Conditions

Interventions

PROCEDURE

Omission of surgery

Patients will not undergo breast and axillary surgery.

Sponsors & Collaborators

  • Institut Curie

    lead OTHER

Principal Investigators

  • Toulsie Ramtohul, MD · Institut Curie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2031-07-31
Completion
2033-07-31

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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 NCT07357948 on ClinicalTrials.gov