Omission of Surgery for Triple-negative Breast Cancer in Complete Response After Neoadjuvant Chemo-immunotherapy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorInstitut Curie
About this 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
Eligibility criteria
Qualifiers
Sex and age: Female, aged 18 years or older.
Histological type: Invasive breast carcinoma of no special type (NST).
Estrogen receptor (ER) < 10%,
Progesterone receptor (PR) < 10%,
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Omission of surgery
Treatment groups
150 Participants
are divided into 2 treatment groupsLocations
4Centre Georges-François Leclerc21000, Dijon France
Hôpital Tenon75020, Paris France
Institut Curie-Paris75005, Paris France
Institut Curie Saint-Cloud92210, Saint-Cloud France
Sponsors and collaborators
Institut Curie
Lead sponsor
Source ClinicalTrials.gov