Clinical trial evaluating the benefit of a post-operative treatment associating radiotherapy + Nivolumab + Ipilimumab versus radiotherapy + Capecitabine for triple negative breast cancer patients with residual disease after neoadjuvant chemotherapy.
- Conditions
- Triple negative breast cancer patients with residual disease after neoadjuvant chemotherapyMedDRA version: 20.0 Level: HLT Classification code 10006292 Term: Breast neoplasms unspecified malignancy System Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2017-003151-34-FR
- Lead Sponsor
- Centre Léon Bérard
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 98
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 <2.2), or
- Immunohistochemistry (IHC): 0-1+, or
- IHC 2-3+ and FISH-negative (FISH ratio <2.2).
Less than 1% of cells stained by immunohistochemestry (IHC) for ER and PR as per ASCO guidelines.
TNBC previously treated by :
Standard neoadjuvant chemotherapy containing anthracycline and taxanes (other drugs may be acceptable following discussion with the Sponsor, with the exclusion of Capecitabine), and
Surgery.
TNBC patients currently treated by post-operative radiotherapy as per standard and/or institutional guidelines: radiotherapy has to be initiated one week (± 3 days) before C1D1.
No radiological evidence of metastatic disease documented by a CT-Scan of Chest abdomen and pelvis.
Residual disease with RCB of Class III documented before randomisation using the surgery specimen.
Availability of a representative formalin-fixed paraffin-embedded (FFPE) tumor block from surgery specimen with its histological report.
Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
Adequate end organ and bone marrow function.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 28
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method