A Phase II Trial of atezolizumab plus carboplatin plus nab-paclitaxel as first-line therapy in metastatic Triple-negative PD-L1 positive breast cancer patients

Consorzio Oncotech19 sites in 1 country104 target enrollmentJanuary 31, 2025

DrugsATEZOLIZUMAB CARBOPLATIN PACLITAXEL ALBUMIN-BOUND

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Not specified
Sponsor: Consorzio Oncotech
Enrollment: 104
Locations: 19
Primary Endpoint: % Overall Survival at 2 years
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To provide preliminary evidence on the efficacy of atezolizumab plus carboplatin plus nab-paclitaxel as first-line therapy in metastatic triple-negative PD-L1 positive breast cancer patients as evaluated by % 2 years OS

Registry

euclinicaltrials.eu

Start Date

January 31, 2025

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

Consorzio Oncotech

Responsible Party

Principal Investigator

Sabino De Placido

Scientific

Consorzio Oncotech

Eligibility Criteria

Inclusion Criteria

•Signed Informed Consent Form
•Previous chemotherapy with taxanes and/or carboplatin for early breast cancer (neoadjuvant or adjuvant setting) is permitted if completed ≥12 months before study entry
•Previous therapy with immune checkpoint inhibitors for early breast cancer (neoadjuvant or adjuvant setting) is permitted if completed ≥12 months before study entry
•ECOG performance status of 0 or 1
•Life expectancy ≥ 12 weeks
•Measurable or evaluable disease as defined by RECIST v1.
•Adequate hematologic and end-organ function, defined by laboratory results obtained within 2 weeks prior to the first study treatment (Cycle 1, Day 1)
•Negative human immunodeficiency virus (HIV) test at screening
•Negative hepatitis B surface antigen (HBsAg) test at screening
•Negative total hepatitis B core antibody (HBcAb) test at screening, or positive HBcAb test followed by a negative hepatitis B virus (HBV) DNA test at screening. The HBV DNA test will be performed only for patients who have a positive HBcAb test

Exclusion Criteria

•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 at least 2 weeks prior to enrollment.
•Presence of an abnormal electrocardiogram (ECG) that is clinically significant in the investigator’s opinion, including complete left bundle branch block, second- or third degree heart block, evidence of prior myocardial infarction, or QT interval corrected using Fridericia’s formula (QTcF) >470 ms demonstrated by at least two consecutive ECGs
•Serious infection requiring antibiotics within 2 weeks prior to enrollment, including but not limited to infections requiring hospitalisation or IV antibiotics, such as bacteremia, or severe pneumonia
•Major surgical procedure within 4 weeks prior to enrollment or anticipation of the need for a major surgical procedure during the study other than for diagnosis Note: Placement of central venous access catheter(s) (e.g., port or similar) is not considered a major surgical procedure and is therefore permitted
•Treatment with investigational therapy within 30 days prior to initiation of study treatment
•History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
•Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary (CHO) cells or any component of the atezolizumab formulation
•History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjögren’s syndrome, Guillain-Barré syndrome, multiple sclerosis (MS), vasculitis, or glomerulonephritis (Note: Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone and patients with controlled Type 1 diabetes mellitus on a stable insulin regimen may be eligible for this study)
•Prior allogeneic stem cell or solid organ transplantation
•History of idiopathic pulmonary fibrosis (IPF, including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest CT scan. (Note: History of radiation pneumonitis in the radiation field [fibrosis] is permitted)