Atezolizumab for Triple negative breast cancer (inoperable locally advanced or metastatic)

Inclusion criteria

• {"criterion_text":"- Patients with unresectable locally advanced or metastatic, histologically locally documented TNBC (negative for HER2 and ER and PgR)."}
• {"criterion_text":"- Patient with at least one specimen positive (primary site and/or metastatic site) for PD-L1 status as determined by VENTANA PD-L1 SP142 IHC assay, performed locally."}
• {"criterion_text":"- Prior treatment with anti-PD-L1/PD-1-containing regimens in the neoadjuvant/adjuvant setting."}
• {"criterion_text":"- Life expectancy ≥12 weeks."}
• {"criterion_text":"- Measurable disease, as defined by RECIST v1.1."}
• {"criterion_text":"- Adequate haematologic and end-organ function"}

Exclusion criteria

• {"criterion_text":"- Patients with de novo mTNBC OR those who have received 1 or more chemotherapy or targeted systemic therapy (including endocrine therapy) or immunotherapy regimens for advanced disease"}
• {"criterion_text":"- Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for > 2 weeks prior to the first dose of study treatment (Cycle 1, Day 1)."}
• {"criterion_text":"- Uncontrolled symptomatic pleural effusion, pericardial effusion, or ascites"}
• {"criterion_text":"- Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results, including significant liver disease"}
• {"criterion_text":"- Significant cardiovascular disease"}

Primary endpoints

• {"endpoint_text":"- overall response rate","definition_or_measurement_approach":"Overall Response Rate (ORR); measurable disease defined by RECIST v1.1."}

Secondary endpoints

• {"endpoint_text":"- Duration of response (DOR)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Progression-free survival (PFS)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Overall survival (OS)","definition_or_measurement_approach":""}
• {"endpoint_text":"- Safety of the combination regimen","definition_or_measurement_approach":""}

Other endpoints

• {"endpoint_text":"- Correlative and translational objectives will investigate antigen-presenting cell(APC) activation (by flow cytometry and single-cell transcriptomic) and SLT generation (by flow cytometry and single-cell transcriptomic) in the peripheral blood (PB) and in intratumoral biopsies before and after treatment.","definition_or_measurement_approach":"Investigations by flow cytometry and single-cell transcriptomic in peripheral blood and intratumoral biopsies before and after treatment."}

Italy

Earliest CTIS Part Ii Submission Date

20-06-2024

Latest Decision Or Authorization Date

14-04-2025

Processing Time Days

298

Number Of Sites

4

Number Of Participants

45

Primary sponsor

Full Name

Istituto Europeo Di Oncologia S.r.l.

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy

Third parties

• {"country":"Italy","full_name":"Consorzio Per Valutazioni Biologiche E Farmacologiche","duties_or_roles":"sponsorDuties code 8","organisation_type":"Pharmaceutical company"}