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Not yet recruitingNCT07357948OMICHIRUpdated Jun 3, 2026

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

An interventional study of Omission of surgery in Triple Negative Breast Cancer and Non-Metastatic, sponsored by Institut Curie. Not yet recruiting at 4 sites in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-03.

Sponsored by Institut Curie · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

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
02

Conditions studied

  • Triple Negative Breast Cancer
  • Non-Metastatic
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    Experimental

    standard care, except surgery

    Procedure: Omission of surgery

  • No intervention
    Control

    standard care, including surgery

Interventions

  • ProcedureOmission of surgery

    Patients will not undergo breast and axillary surgery.

05

What researchers measure

Primary outcomes

  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.

    Time frame: Within 36 months after randomisation

Secondary outcomes

  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)

    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

  2. Assessing distant recurrence-free interval (DRFI)

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

    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

  3. Assessing overall survival (OS)

    Number of months between randomization and death, regardless of cause

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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

    Time frame: 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)

    Time frame: At surgery

06

Study locations

4 sites
  • Centre Georges-François Leclerc
    Dijon, 21000, France
    • Charles COUTANT, MD · Contact
    • Charles COUTANT, MD · Principal investigator
  • Institut Curie-Paris
    Paris, 75005, France
    • RAMTOHUL, MD · Contact
    • Toulsie RAMTOHUL, MD · Principal investigator
  • Hôpital Tenon
    Paris, 75020, France
    • Anne SABAILA, MD · Contact
    • Anne SABAILA, MD · Principal investigator
  • Institut Curie Saint-Cloud
    Saint-Cloud, 92210, France
    • Katia MAHIOU, MD · Contact
    • Katia MAHIOU, MD · Principal investigator
07

References and documents

Individual participant data

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

Supporting information: Study protocol, Sap

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07357948
Lead sponsor
Institut Curie
Responsible party
Sponsor
First posted
Jan 22, 2026
Start date
Aug 1, 2026 (estimated)
Primary completion
Jul 31, 2031 (estimated)
Completion
Jul 31, 2033 (estimated)
Last update
Jun 3, 2026

Study contacts

Carole Cagnot, Ph.D
Contact
drci.promotion@curie.fr
0147111891
Toulsie Ramtohul, MD
principal investigator · Institut Curie

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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