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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Omission of surgery
Procedure/SurgeryPatients will not undergo breast and axillary surgery.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: ExperimentalExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
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 randomisationSecondary 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 months2
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 months3
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 months4
Assessing the adverse effects of macrobiopsy
Number of adverse events
Time frame
Up to 30 days after macrobiopsySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: