Breast cancer
Conditions
Brief summary
Central evaluation of pathological complete response rate as defined as absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes following completion of NAST (i.e., ypT0/is, ypN0 in the current AJCC staging system), Dose Limiting Toxicity (DLT) rates as defined as incidence of DLT during the 21 days following the first administration of pembrolizumab in combination with EC, will be assessed in the first 6 patients
Detailed description
Occurrence of serious adverse events and adverse events starting grade 2 or grade 1 (run-in period) according to the National Cancer Institute (NCI) Common Terminology Criteria for Ad-verse Events (CTCAE) V5.0, Local evaluation of pathological complete response rate as defined as absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes following completion of NAST (i.e., ypT0/is, ypN0 in the current AJCC staging system), Invasive disease-free survival (IDFS), as defined as time from surgery to the first documented occurrence of an event, defined as: Ipsilateral invasive breast tumor recurrence or Ipsilateral local-regional invasive breast cancer recurrence or Distant recurrence or contralateral invasive breast cancer or death from any cause, Event free survival (EFS), defined as time from randomization to disease progression, disease recurrence (local, regional, distant, or contralateral [invasive or non-invasive]), or death from any cause), Overall survival (OS), defined as time from randomization to death from any cause
Interventions
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
DRUGENDOXAN 1000 mg
DRUGpoudre pour solution injectable
DRUGEPIRUBICINE MEDAC 2 mg/ml
DRUGsolution pour perfusion
Sponsors
Institut Paoli Calmettes
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Central evaluation of pathological complete response rate as defined as absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes following completion of NAST (i.e., ypT0/is, ypN0 in the current AJCC staging system), Dose Limiting Toxicity (DLT) rates as defined as incidence of DLT during the 21 days following the first administration of pembrolizumab in combination with EC, will be assessed in the first 6 patients | — |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of serious adverse events and adverse events starting grade 2 or grade 1 (run-in period) according to the National Cancer Institute (NCI) Common Terminology Criteria for Ad-verse Events (CTCAE) V5.0, Local evaluation of pathological complete response rate as defined as absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes following completion of NAST (i.e., ypT0/is, ypN0 in the current AJCC staging system), Invasive disease-free survival (IDFS), as defined as time from surgery to the first documented occurrence of an event, defined as: Ipsilateral invasive breast tumor recurrence or Ipsilateral local-regional invasive breast cancer recurrence or Distant recurrence or contralateral invasive breast cancer or death from any cause, Event free survival (EFS), defined as time from randomization to disease progression, disease recurrence (local, regional, distant, or contralateral [invasiv | — |
Countries
France
Outcome results
None listed