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Triple Negative Breast CancerOMICHIRNCT07357948

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

A study testing Omission of surgery in people with Triple Negative Breast Cancer and Non-Metastatic, run by Institut Curie at 4 sites in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Triple Negative Breast Cancer, Non-Metastatic
What is being tested?
Omission of surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
4 sitesFrance
Study dates
1 Aug 2026to 31 Jul 2033
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Sex and age: Female, aged 18 years or older.
  • Histological type: Invasive breast carcinoma of no special type (NST).
  • 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).
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  • High proliferation index: Ki-67 > 30%.
  • Primary tumor classified as T2, i.e. tumor size between 2 and 5 cm on imaging at diagnosis (mammography, ultrasound, and breast MRI).
  • No regional lymph node involvement or distant metastasis, confirmed by 18F-FDG PET-CT performed prior to neoadjuvant treatment.
  • Completion of the full neoadjuvant chemo-immunotherapy (NCIT) protocol according to the KEYNOTE-522 regimen (≥7 cycles including pembrolizumab).
  • Breast-conserving surgery deemed feasible based on the initial surgical assessment.
  • 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.
  • Written informed consent obtained prior to any study-specific procedure.
  • Ability of the patient to comply with the protocol requirements and scheduled follow-up.
  • Affiliation with a national health insurance system, in accordance with French regulations.

Who cannot join

  • Presence of regional recurrence or metastatic disease at inclusion.
  • History of thoracic, breast, or regional lymph node irradiation, regardless of indication.
  • Invasive lobular carcinoma, excluded due to its different response profile and increased risk of multifocal residual disease.
  • Presence of ductal carcinoma in situ (DCIS) on diagnostic biopsy, or diffuse suspicious microcalcifications on mammography, precluding reliable assessment of complete response.
  • Bilateral breast cancer (except for localized and treated contralateral DCIS), or history of ipsilateral or contralateral invasive breast cancer.
  • Multifocal or multicentric disease detected on imaging (mammography, ultrasound, or breast MRI).
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  • Skin involvement or inflammatory breast cancer, identified on imaging or clinical examination.
  • 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.
  • Severe or progressive non-malignant disease limiting life expectancy to less than 10 years, in the investigator's judgment.
  • Presence of a high-risk germline mutation predisposing to breast cancer (including BRCA1, BRCA2, or other identified predisposition genes).
  • Participation in another interventional clinical trial within 30 days prior to inclusion.
  • Current pregnancy or breastfeeding.
  • Cognitive impairment, psychiatric disorder, or social situation preventing valid informed consent or adequate understanding of the protocol, as assessed by the investigator.
  • Individuals deprived of liberty or under legal protection (guardianship, curatorship, or similar legal status), in accordance with applicable regulations.

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Carole Cagnot, Ph.D contact

0147111891

drci.promotion@curie.fr

France4 sites

  • Centre Georges-François Leclerc

    Dijon, 21000

    Charles COUTANT, MD

    Charles COUTANT, MD

  • Institut Curie-Paris

    Paris, 75005

    RAMTOHUL, MD

    Toulsie RAMTOHUL, MD

  • Hôpital Tenon

    Paris, 75020

    Anne SABAILA, MD

    Anne SABAILA, MD

  • Institut Curie Saint-Cloud

    Saint-Cloud, 92210

    Katia MAHIOU, MD

    Katia MAHIOU, MD

Other trials in France

About this study

Official title: 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
Being tested
Omission of surgery
Medical subject headings
Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Omission of surgeryProcedure or surgery

    Patients will not undergo breast and axillary surgery.

Study groups in NCT07357948
Study groupRoleWhat they receive
ExperimentalExperimentalstandard care, except surgery
Receives: Procedure: Omission of surgery
ControlNo interventionstandard care, including surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assess invasive disease-free survival (iDFS)

    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.

    Measured: Within 36 months after randomisation

Secondary outcomes (13)

  1. Assessing the locoregional recurrence-free interval (LRFI)

    Number of months between randomization and the first occurrence of local or regional invasive recurrence (in the breast or regional lymph nodes)

    Measured: 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

  2. Assessing distant recurrence-free interval (DRFI)

    Number of months between randomization and the first occurrence of distant metastases

    Measured: 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

  3. Assessing overall survival (OS)

    Number of months between randomization and death, regardless of cause

    Measured: From date of randomisation until the date of death, assessed up to 60 months

  4. Assessing the adverse effects of macrobiopsy

    Number of adverse events

    Measured: Up to 30 days after macrobiopsy

  5. Assessing the adverse effects of standard of care radiotherapy treatment

    Number of grade ≥ 3 adverse events related to radiotherapy

    Measured: From start of treatment through study completion, an average of 60 months

  6. Assessing quality of life - EORTC QLQ-C30 Physical Functioning score

    EORTC QLQ-C30 Physical Functioning score (0-100; higher = better)

    Measured: Randomisation, month 6, month 12, month 18, month 24, month 30, month 36

  7. Assessing quality of life - EORTC QLQ-C30 Fatigue score

    EORTC QLQ-C30 Fatigue score (0-100; higher = worse)

    Measured: Randomisation, month 6, month 12, month 18, month 24, month 30, month 36

  8. Assessing quality of life - EORTC QLQ-C30 Global Health Status/Quality of Life score

    EORTC QLQ-C30 Global Health Status/Quality of Life score (0-100; higher = better)

    Measured: Randomisation, month 6, month 12, month 18, month 24, month 30, month 36

  9. Assessing quality of life and aesthetic results - EORTC QLQ-BR42 Body Image score

    EORTC QLQ-BR42 Body Image score (0-100; higher = better)

    Measured: Randomisation, month 6, month 12, month 18, month 24, month 30, month 36

  10. Assessing quality of life and aesthetic results - EORTC QLQ-BR42 Arm Symptoms score

    EORTC QLQ-BR42 Arm Symptoms score (0-100; higher = worse)

    Measured: Randomisation, month 6, month 12, month 18, month 24, month 30, month 36

  11. Assessing quality of life and aesthetic results - EORTC QLQ-BR42 Future Perspective score

    EORTC QLQ-BR42 Future Perspective score (0-100; higher = better)

    Measured: Randomisation, month 6, month 12, month 18, month 24, month 30, month 36

  12. Assessing the number of benign biopsies during follow-up

    Number of benign biopsies of the breast or ipsilateral lymph nodes performed during follow-up

    Measured: From date of randomisation until the date of new biopsy, assessed up to 60 months

  13. Number of patients with residual disease not detected in the control arm

    Evaluating the performance of MRI and macrobiopsy for predicting complete histologic response (pCR)

    Measured: At surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2026
  2. Study start1 Aug 2026 (estimated)
  3. Primary completion31 Jul 2031 (estimated)
  4. Study completion31 Jul 2033 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07357948
Sponsor's protocol ID
IC 2025-05
Other IDs
2025-A02926-43
Acronym
OMICHIR
Status last verified
Jan 2026
First submitted
5 Jan 2026
Last updated
3 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies

Questions about this trial

What is this clinical trial studying?

A study testing Omission of surgery in people with Triple Negative Breast Cancer and Non-Metastatic, run by Institut Curie at 4 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Carole Cagnot, Ph.D (0147111891, drci.promotion@curie.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assess invasive disease-free survival (iDFS) (time frame: Within 36 months after randomisation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07357948.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.

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