Triple negative breast cancer patients with residual disease after neoadjuvant chemotherapy MedDRA version: 20.0 Level: HLT Classification code 10006292 Term: Breast neoplasms unspecified malignancy System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Opdivo
Product Name: Nivolumab
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: NIVOLUMAB
CAS Number: NIVOLUMAB
Current Sponsor code: ET17-093
Other descriptive name: NIVOLU
Sponsors
Centre Léon Bérard
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Female patient > 18 years of age on day of signing informed consent form. Histologically proven TNBC defined as follows: HER2 negativity must be confirmed by one of the following: - Fluorescence in situ hybridization (FISH) negative (FISH ratio =65 years) no F.1.3.1 Number of subjects for this age range 28
Exclusion criteria
Exclusion criteria: Patient has a metastatic breast cancer. Patient has previously received therapy with an anti- PD-1, anti- PD-L1, or anti-CTLA4 or any other immunotherapies. Patient has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone curative therapy and other completely treated prior malignancy if no evidence of disease for = 2 years. Patient presents a contraindication to Nivolumab or Ipilimumab treatment as per respective SPC including known hypersensitivity to one of these study drugs or severe hypersensitivity reaction to any monoclonal antibody. Patient presents a contraindication to Capecitabine treatment as per SPC including i) History of severe and unexpected reactions to fluoropyrimidine therapy, 2) Hypersensitivity to Capecitabine or to any of the excipients listed in SPC or fluorouracil, 3) Patients with known complete absence of dihydropyrimidine dehydrogenase activity, 4) Treatment with sorivudine or its chemically related analogues, such as brivudine, 5) any contraindication listed in respective SPC. Patient has active autoimmune disease that has required systemic treatment in the past 3 months before C1D1 or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids at doses higher than 10 mg/d prednisone equivalents or immunosuppressive agents.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the clinical benefit of a post-operative adjuvant therapy combining radiotherapy + Nivolumab + Ipilimumab versus radiotherapy + Capecitabine in TNBC patients with residual disease after neoadjuvant chemotherapy.;Secondary Objective: To further assess the clinical impact of the proposed combination in the target population. To further evaluate the safety profile of the proposed combination in the target population. To assess the impact of the proposed combinations on patient’ quality of life in the target population.;Primary end point(s): Disease free survival ;Timepoint(s) of evaluation of this end point: 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Overall Survival . Local-regional recurrence rate. Distant metastasis rate. Incidence of AEs, related AEs, irAE, Grade = 3 AEs, AESI, SAEs, SUSARs graded using NCI CTCAE 5.0 Patients reported outcomes EORTC QLQ-C30, EORTC QLQ BR-23, EORTC QLQ FA-13 Fatigue, GAD7 patient self-rating mood scale.;Timepoint(s) of evaluation of this end point: 2 years | — |
Countries
France
Contacts
Public ContactDRCI
Centre Léon Bérard
Outcome results
None listed