Nivolumab for Triple-negative breast cancer (metastatic)

Inclusion criteria

• {"criterion_text":"- Metastatic or incurable locally advanced triple negative breast cancer with confirmation of ER and HER2 negativity (ER <10% and HER2 IHC 0,1+ or 2+ in the absence of amplification)\n- Metastatic lesion accessible for histological biopsy\n- 18 years or older\n- Maximum of three lines of chemotherapy for metastatic disease and with evidence of progression of disease\n- WHO performance status of 0 or 1\n- Measurable or evaluable disease according to RECIST 1.1\n- Disease Free Interval (defined as time between first diagnosis or locoregional recurrence and first metastasis) longer than 1 year. This does not apply to patients with de novo metastatic disease or patients who did not receive (neo)adjuvant chemotherapy"}

Exclusion criteria

• {"criterion_text":"- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris\n- Known history of leptomeningeal disease localization\n- History of having received other anticancer therapies within 2 weeks of start of the study drug\n- History of immunodeficiency, autoimmune disease, conditions requiring immunosuppression (>10 mgl daily prednisone equivalents) or chronic infections\n- Prior treatment with immune checkpoint inhibitors"}

Primary endpoints

• {"endpoint_text":"- Progression-free survival as measured by the proportion of patients free of progression after 6 cycles of nivolumab (PFS1: time from randomization to tumor progression or death from any cause) according to RECIST1.1","definition_or_measurement_approach":"PFS1 defined as time from randomization to tumor progression or death from any cause; progression assessed according to RECIST 1.1"}

Secondary endpoints

• {"endpoint_text":"- Response as measured by the objective response rate (ORR: complete responses or partial responses) according to iRECIST and RECIST1.1","definition_or_measurement_approach":"Objective response rate (ORR) assessed per iRECIST and RECIST 1.1 (complete or partial responses)"}
• {"endpoint_text":"- Clinical benefit as measured by the clinical benefit rate (CBR) according to RECIST 1.1 and iRECIST","definition_or_measurement_approach":"Clinical benefit rate (CBR) assessed per RECIST 1.1 and iRECIST"}
• {"endpoint_text":"- PFS1 according to RECIST 1.1 and iRECIST","definition_or_measurement_approach":"PFS1 assessed using RECIST 1.1 and iRECIST"}
• {"endpoint_text":"- Overall survival (OS: time from nivolumab initiation to death from any cause)","definition_or_measurement_approach":"OS defined as time from nivolumab initiation to death from any cause"}
• {"endpoint_text":"- Percentage of patients with toxicity (CTCAE v5.0) and immune-related toxicity","definition_or_measurement_approach":"Safety assessed by percentage of patients experiencing toxicities graded using CTCAE v5.0, including immune-related toxicity"}
• {"endpoint_text":"- PFS as measured by the proportion of patients free of progression after 6 cycles of nivolumab (PFS2: time from randomization to tumor progression or death from any cause). Progression as defined by RECIST 1.1 and iRECIST will be used","definition_or_measurement_approach":"PFS2 defined as time from randomization to tumor progression or death from any cause; progression assessed per RECIST 1.1 and iRECIST"}

Netherlands

Earliest CTIS Part Ii Submission Date

26-03-2024

Latest Decision Or Authorization Date

13-01-2025

Processing Time Days

293

Number Of Sites

1

Number Of Participants

34

Primary sponsor

Full Name

Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands