Nivolumab for Triple-negative breast cancer (metastatic)

Inclusion criteria

• {"criterion_text":"- Metastatic ER and HER2 negative breast cancer\n- 18 years or older\n- Metastatic lesions accessible for histological biopsy\n- Maximum of three lines of chemotherapy for metastatic disease\n- Evaluable disease according to RECIST 1.1\n- WHO performance status 0 or 1\n- Subjects with brain metastases are eligible if these have been treated and there is no magnetic resonance imaging (MRI) evidence of progression for at least 4 weeks after treatment is completed and prior to first dose of study drug administration. There must also be no requirement for immunosuppressive doses of systemic corticosteroids (> 10 mg/day prednisone equivalents) for at least 2 weeks prior to study drug administration\n- Signed written informed consent"}

Exclusion criteria

• {"criterion_text":"- Known leptomenigeal disease localization\n- History of having recceived other anticancer therapies within 2 weeks of start of the study drug\n- History of immunodeficiency, autoimmune disease, conditions requiring immunosuppression (>10 mg daily prednisone equivalents) or chronic infections\n- Current pregnancy or breastfeeding"}

Primary endpoints

• {"endpoint_text":"- Progression-free survival (=PFS1, time from randomization to tumor progression or death from any cause). Progression as defined by RECIST 1.1 will be used.","definition_or_measurement_approach":"Time from randomization to tumor progression or death from any cause; progression defined by RECIST 1.1."}

Secondary endpoints

• {"endpoint_text":"- Progression-free survival (=PFS1, time from randomization to tumor progression or death from any cause). Progression as defined by modified RECIST 1.1 for immune-based therapeutics (iRECIST) will be used.","definition_or_measurement_approach":"Time from randomization to tumor progression or death; progression assessed by modified RECIST 1.1 for immune-based therapeutics (iRECIST)."}
• {"endpoint_text":"- Progression-free survival (=PFS2, time from nivolumab treatment initiation to tumor progression). Progression as defined by RECIST 1.1 and iRECIST will be used.","definition_or_measurement_approach":"Time from nivolumab initiation to tumor progression; progression assessed by RECIST 1.1 and iRECIST."}
• {"endpoint_text":"- Overall response rate ORR (complete response CR or partial response PR) according to RECIST 1.1 and iRECIST. ORR1 (relative to randomization) and ORR2 (relative to nivolumab initiation) will be used.","definition_or_measurement_approach":"Proportion of patients with CR or PR per RECIST 1.1 and iRECIST; ORR measured relative to randomization (ORR1) and relative to nivolumab initiation (ORR2)."}
• {"endpoint_text":"- Clinical benefit rate (CR+PR+stable disease ≥ 6 months and CR+PR+stable disease ≥ 3 months) according to RECIST 1.1 and iRECIST. CBR1 (relative to randomization) and CBR2 (relative to nivolumab initiation) will be used.","definition_or_measurement_approach":"Proportion of patients with CR, PR or stable disease lasting ≥6 months and ≥3 months per RECIST 1.1 and iRECIST; CBR reported relative to randomization (CBR1) and nivolumab initiation (CBR2)."}
• {"endpoint_text":"- Overall survival (OS, time from nivolumab initiation to death from any cause).","definition_or_measurement_approach":"Time from nivolumab initiation to death from any cause."}
• {"endpoint_text":"- Percentage of patients with toxicity (classified according to CTCAE v4.0) and immune-related toxicity.","definition_or_measurement_approach":"Proportion of patients experiencing adverse events graded by CTCAE v4.0 and assessment of immune-related toxicities."}

Netherlands

Earliest CTIS Part Ii Submission Date

21-01-2025

Latest Decision Or Authorization Date

24-01-2025

Processing Time Days

3

Number Of Sites

1

Number Of Participants

84

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

Third parties

• {"country":"","full_name":"Bristol-Myers Squibb International Corporation","duties_or_roles":"Monetary support","organisation_type":"Company/Industry"}