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Neo-CheckRay
NCT03875573Phase 2
Key facts
- Status
- Active, not recruiting
- Start
- Nov 2019
- Primary completion
- Nov 2024
- Countries
- 2
- Sponsor
- Institut Jules Bordet
- Modality
- Prophylactic Vaccines, Antibody Conjugates, Therapeutic Vaccines
- Drugs
- durvalumaboleclumab
- Conditions
- breast cancer
01
Overview
Phase 2, randomised, open-label trial of durvalumab and oleclumab in breast cancer (3 arms), sponsored by Institut Jules Bordet. Primary endpoints: Evaluation of the immune related or radiation therapy related toxicity of special interest at 7 months, Evaluation of the feasibility of the primary surgery at 7 months and 1 more. Started Nov 2019; status: active, not recruiting.
02
Design
3 arms- Study design
- RandomizedOpen-label
Chemotherapy and radiotherapy
Paclitaxel + ddAC + SBRT
Chemotherapy and pre-operative radiotherapy plus durvalumab
Paclitaxel + ddAC + SBRT + Durvalumab
Chemotherapy & pre-op radiotherapy + durvalumab + oleclumab
Paclitaxel + ddAC + SBRT + Durvalumab + Oleclumab
03
Who it enrols
Female patients ≥ 18 years with ER-positive, HER2-negative luminal B breast adenocarcinoma (Ki67 ≥ 15% or grade III, MammaPrint high risk), ECOG ≤ 1, adequate organ function, and no prior radiotherapy to the ipsilateral breast or prior immunotherapy.
04
Endpoints
Primary
Evaluation of the immune related or radiation therapy related toxicity of special interest
Evaluation of the feasibility of the primary surgery
Demonstration of the tumour response in arms 2 or 3 versus arm 1
Secondary
Evaluation of the complete pathological response rate defined as ypT0/Tis ypN0
Evaluation of the complete pathological response rate defined as ypT0 ypN0
Evaluation of the response to the primary tumour irrespective of the response to the pathological lymph nodes
Evaluation of the response to the pathological lymph nodes irrespective of the response to the primary tumour
Evaluation of the feasibility to perform breast-sparing surgery of the arms 2 and 3 versus arm 1
Demonstration of an increase in TIL levels of the primary breast cancer between baseline and the week 6 biopsy
Evaluation of the ability to control invasive disease and survival in arms 2 and 3 versus arm 1 at year 3 and 5 years after surgery
Evaluation of the severity and duration of AEs of the arms 2 and 3 versus arm 1
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