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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
Patients will not undergo breast and axillary surgery.
Centre Georges-François Leclerc
Dijon, France
Institut Curie-Paris
Paris, France
Hôpital Tenon
Paris, France
Institut Curie Saint-Cloud
Saint-Cloud, France
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
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
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
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
Assessing the adverse effects of macrobiopsy
Number of adverse events
Time frame: Up to 30 days after macrobiopsy
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
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
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
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
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
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
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
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
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
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