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

June 1, 2026 updated by: Institut Curie

Omission of Surgery for Triple-negative Breast Cancer in Complete Response Confirmed by MRI and Macrobiopsy After Neoadjuvant Chemo-immunotherapy: a Randomized, Multicenter Phase II Trial.

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Dijon, France, 21000
        • Centre Georges-Francois Leclerc
        • Contact:
          • Charles COUTANT, MD
        • Principal Investigator:
          • Charles COUTANT, MD
      • Paris, France, 75020
        • Hopital Tenon
        • Contact:
          • Anne SABAILA, MD
        • Principal Investigator:
          • Anne SABAILA, MD
      • Paris, France, 75005
        • Institut Curie-Paris
        • Contact:
          • RAMTOHUL, MD
        • Principal Investigator:
          • Toulsie RAMTOHUL, MD
      • Saint-Cloud, France, 92210
        • Institut Curie Saint-Cloud
        • Contact:
          • Katia MAHIOU, MD
        • Principal Investigator:
          • Katia MAHIOU, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Sex and age: Female, aged 18 years or older.
  2. Histological type: Invasive breast carcinoma of no special type (NST).

  3. Triple-negative phenotype, defined by:

    • Estrogen receptor (ER) < 10%,
    • Progesterone receptor (PR) < 10%,
    • HER2-negative status according to ASCO/CAP criteria (IHC score 0-1+, or 2+ without amplification by in situ hybridization).
  4. High proliferation index: Ki-67 > 30%.
  5. Primary tumor classified as T2, i.e. tumor size between 2 and 5 cm on imaging at diagnosis (mammography, ultrasound, and breast MRI).
  6. No regional lymph node involvement or distant metastasis, confirmed by 18F-FDG PET-CT performed prior to neoadjuvant treatment.
  7. Completion of the full neoadjuvant chemo-immunotherapy (NCIT) protocol according to the KEYNOTE-522 regimen (≥7 cycles including pembrolizumab).
  8. Breast-conserving surgery deemed feasible based on the initial surgical assessment.
  9. Radiological complete response (rCR) on post-NCIT breast MRI, associated with a negative vacuum-assisted biopsy (VAB) of the clip-marked tumor bed, confirming the absence of residual invasive or in situ disease.
  10. Written informed consent obtained prior to any study-specific procedure.
  11. Ability of the patient to comply with the protocol requirements and scheduled follow-up.
  12. Affiliation with a national health insurance system, in accordance with French regulations.

Exclusion Criteria:

  1. Presence of regional recurrence or metastatic disease at inclusion.
  2. History of thoracic, breast, or regional lymph node irradiation, regardless of indication.
  3. Invasive lobular carcinoma, excluded due to its different response profile and increased risk of multifocal residual disease.
  4. Presence of ductal carcinoma in situ (DCIS) on diagnostic biopsy, or diffuse suspicious microcalcifications on mammography, precluding reliable assessment of complete response.
  5. Bilateral breast cancer (except for localized and treated contralateral DCIS), or history of ipsilateral or contralateral invasive breast cancer.
  6. Multifocal or multicentric disease detected on imaging (mammography, ultrasound, or breast MRI).
  7. Skin involvement or inflammatory breast cancer, identified on imaging or clinical examination.

  8. History of malignancy other than breast cancer, unless the disease has been in complete remission for ≥ 5 years and is considered at low risk of recurrence, with the exception of:

    • Treated carcinoma in situ of the cervix, endometrium, or colon,
    • Melanoma in situ,
    • Completely excised cutaneous basal cell or squamous cell carcinoma.
  9. Severe or progressive non-malignant disease limiting life expectancy to less than 10 years, in the investigator's judgment.
  10. Presence of a high-risk germline mutation predisposing to breast cancer (including BRCA1, BRCA2, or other identified predisposition genes).
  11. Participation in another interventional clinical trial within 30 days prior to inclusion.
  12. Current pregnancy or breastfeeding.
  13. Cognitive impairment, psychiatric disorder, or social situation preventing valid informed consent or adequate understanding of the protocol, as assessed by the investigator.
  14. Individuals deprived of liberty or under legal protection (guardianship, curatorship, or similar legal status), in accordance with applicable regulations.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental
standard care, except surgery
Procedure: Omission of surgery
Patients will not undergo breast and axillary surgery.
No Intervention: Control
standard care, including surgery

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Assess invasive disease-free survival (iDFS)
Time Frame: Within 36 months after randomisation
Disease-free survival rate, taking into account the first occurrence of any of the following events : local or regional invasive recurrence, contralateral invasive breast cancer, distant metastasis, second primary cancer, death from any cause.
Within 36 months after randomisation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assessing the locoregional recurrence-free interval (LRFI)
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Number of months between randomization and the first occurrence of local or regional invasive recurrence (in the breast or regional lymph nodes)
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Assessing distant recurrence-free interval (DRFI)
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Number of months between randomization and the first occurrence of distant metastases
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
Assessing overall survival (OS)
Time Frame: From date of randomisation until the date of death, assessed up to 60 months
Number of months between randomization and death, regardless of cause
From date of randomisation until the date of death, assessed up to 60 months
Assessing the adverse effects of macrobiopsy
Time Frame: Up to 30 days after macrobiopsy
Number of adverse events
Up to 30 days after macrobiopsy
Assessing the adverse effects of standard of care radiotherapy treatment
Time Frame: From start of treatment through study completion, an average of 60 months
Number of grade ≥ 3 adverse events related to radiotherapy
From start of treatment through study completion, an average of 60 months
Assessing quality of life - EORTC QLQ-C30 Physical Functioning score
Time Frame: Randomisation, month 6, month 12, month 18, month 24, month 30, month 36
EORTC QLQ-C30 Physical Functioning score (0-100; higher = better)
Randomisation, month 6, month 12, month 18, month 24, month 30, month 36
Assessing quality of life - EORTC QLQ-C30 Fatigue score
Time Frame: Randomisation, month 6, month 12, month 18, month 24, month 30, month 36
EORTC QLQ-C30 Fatigue score (0-100; higher = worse)
Randomisation, month 6, month 12, month 18, month 24, month 30, month 36
Assessing quality of life - EORTC QLQ-C30 Global Health Status/Quality of Life score
Time Frame: Randomisation, month 6, month 12, month 18, month 24, month 30, month 36
EORTC QLQ-C30 Global Health Status/Quality of Life score (0-100; higher = better)
Randomisation, month 6, month 12, month 18, month 24, month 30, month 36
Assessing quality of life and aesthetic results - EORTC QLQ-BR42 Body Image score
Time Frame: Randomisation, month 6, month 12, month 18, month 24, month 30, month 36
EORTC QLQ-BR42 Body Image score (0-100; higher = better)
Randomisation, month 6, month 12, month 18, month 24, month 30, month 36
Assessing quality of life and aesthetic results - EORTC QLQ-BR42 Arm Symptoms score
Time Frame: Randomisation, month 6, month 12, month 18, month 24, month 30, month 36
EORTC QLQ-BR42 Arm Symptoms score (0-100; higher = worse)
Randomisation, month 6, month 12, month 18, month 24, month 30, month 36
Assessing quality of life and aesthetic results - EORTC QLQ-BR42 Future Perspective score
Time Frame: Randomisation, month 6, month 12, month 18, month 24, month 30, month 36
EORTC QLQ-BR42 Future Perspective score (0-100; higher = better)
Randomisation, month 6, month 12, month 18, month 24, month 30, month 36
Assessing the number of benign biopsies during follow-up
Time Frame: From date of randomisation until the date of new biopsy, assessed up to 60 months
Number of benign biopsies of the breast or ipsilateral lymph nodes performed during follow-up
From date of randomisation until the date of new biopsy, assessed up to 60 months
Number of patients with residual disease not detected in the control arm
Time Frame: At surgery
Evaluating the performance of MRI and macrobiopsy for predicting complete histologic response (pCR)
At surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institut Curie

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Toulsie Ramtohul, MD, Institut Curie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2031

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2033

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 5, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IC 2025-05
  • 2025-A02926-43 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies

IPD Sharing Time Frame

Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months

IPD Sharing Access Criteria

ccess to trial individual participant data can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a data sharing agreement (DSA).

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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