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

NCT07357948 | Not Yet Recruiting DMC

• 2 other identifiers: IC 2025-052025-A02926-43
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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

Triple Negative Breast Cancer; Non-Metastatic

Outcome Measures

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.

  Within 36 months after randomisation

Secondary Outcomes (13)

• Assessing the locoregional recurrence-free interval (LRFI)

  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)

  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)

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

• Assessing the adverse effects of macrobiopsy

  Up to 30 days after macrobiopsy

• Assessing the adverse effects of standard of care radiotherapy treatment

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

Study Arms (2)

Experimental

EXPERIMENTAL

standard care, except surgery

Procedure: Omission of surgery

Control

NO INTERVENTION

standard care, including surgery

Interventions

Omission of surgery PROCEDURE

Patients will not undergo breast and axillary surgery.

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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).
• 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).
• 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.

Sponsors & Collaborators

• Institut Curie: lead

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Toulsie Ramtohul, MD

  Institut Curie

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carole Cagnot, Ph.D

CONTACT

0147111891; drci.promotion@curie.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: January 22, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): July 31, 2031
• Study Completion (Estimated): July 31, 2033
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data requests can be submitted starting 9 months after last article publication and will be made accessible for up to 12 months
• 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).