Luminal B Breast Cancer
Conditions
Brief summary
Residual cancer burden (RCB 0-1 vs. RCB 2-3) at time of surgery. RCB 0 is defined as pathological complete response (pCR) and RCB 1 is defined as minimal residual disease. RCB is calculated as a continuous index combining pathologic measurements of the primary tumour (size and cellularity) and nodal metastases (number and size) as defined by Symmans et al. (15).
Detailed description
At surgery: • Rate of pCR - ypT0/Tis ypN0, defined as the absence of residual invasive cancer at the time of definitive surgery., Rate of pCR - no DCIS (yp DCIS (ypT0 ypN0), defined as the absence of residual invasive and in situ cancer at time of definitive surgery, Complete pathologic response rate (pCR) of the primary tumour (ypT0/ Tis), irrespective of the response rate of the resected nodal metastases., Complete pathologic response rate (pCR) of the resected nodal metastases (ypN0), irrespective of the response rate of the primary tumour., % of breast conservation surgery in arms 2 and 3 versus arm 1, Change in TIL levels between baseline and the week 6 biopsy., Follow-up Phase: Efficacy endpoints at 3 years and 5 years after surgery will be measured, as defined by the Standardized Definitions for Efficacy End Points in Neoadjuvant Breast Cancer Clinical Trials (NeoSTEEP) (88). The following endpoints will be assessed: event-free survival (EFS), breast cancer event-free survival (BC-EFS), overall survival (OS) and distant recurrence-free survival (DRFS). Furthermore, the occurrence of ipsilateral locoregional recurrence (breast, chestwall or lo
Interventions
DRUGCYCLOPHOSPHAMIDE
DRUGDoxorubicin 2 mg/ml Concentrate for Solution for Infusion
DRUGDURVALUMAB
DRUGOleclumab_IJB2
Sponsors
Institut Jules Bordet
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Residual cancer burden (RCB 0-1 vs. RCB 2-3) at time of surgery. RCB 0 is defined as pathological complete response (pCR) and RCB 1 is defined as minimal residual disease. RCB is calculated as a continuous index combining pathologic measurements of the primary tumour (size and cellularity) and nodal metastases (number and size) as defined by Symmans et al. (15). | — |
Secondary
| Measure | Time frame |
|---|---|
| At surgery: • Rate of pCR - ypT0/Tis ypN0, defined as the absence of residual invasive cancer at the time of definitive surgery., Rate of pCR - no DCIS (yp DCIS (ypT0 ypN0), defined as the absence of residual invasive and in situ cancer at time of definitive surgery, Complete pathologic response rate (pCR) of the primary tumour (ypT0/ Tis), irrespective of the response rate of the resected nodal metastases., Complete pathologic response rate (pCR) of the resected nodal metastases (ypN0), irrespective of the response rate of the primary tumour., % of breast conservation surgery in arms 2 and 3 versus arm 1, Change in TIL levels between baseline and the week 6 biopsy., Follow-up Phase: Efficacy endpoints at 3 years and 5 years after surgery will be measured, as defined by the Standardized Definitions for Efficacy End Points in Neoadjuvant Breast Cancer Clinical Trials (NeoSTEEP) (88). The following endpoints will be assessed: event-free survival (EFS), breast cancer event-free | — |
Countries
Belgium, France
Outcome results
None listed