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

Sponsor
Institut Curie
Study ID
NCT07357948
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Omission of surgery — PROCEDURE
    Patients will not undergo breast and axillary surgery.

Study Details

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

Key Dates

First listed
Jan 22, 2026
Start date
Aug 1, 2026
Status verified
Jan 2026
Primary completion
Jul 31, 2031
Completion
Jul 31, 2033

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental
    standard care, except surgery
  • No Intervention: Control
    standard care, including surgery

Primary Outcome Measure

Assess invasive disease-free survival (iDFS) [ Time Frame: Within 36 months after randomisation ]

Central Contacts

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