Phase II Study of Atezolizumab with Vinorelbine and Cyclophosphamide for First Line Treatment of Metastatic Triple Negative Breast Cancer in Patients Previously Treated with Anti-PD-L1PD-1 Therapy

What this Trial Is About

Triple-negative breast cancer TNBC is a very aggressive and deadly form of breast cancer with limited effective treatments available. Researchers are evaluating a combination of the immune therapy drug atezolizumab with chemotherapy drugs cyclophosphamide and vinorelbine. This phase II trial aims to measure the overall response rate of this combination in patients with advanced or metastatic TNBC who have previously been treated with anti-PD-1 or anti-PD-L1 therapies. Participants will receive atezolizumab intravenously at 840 mg on days 1 and 15 of each 28-day cycle. Cyclophosphamide will be given intravenously at 300 mgm2 on days 1, 8, 15, and 21, while vinorelbine will be taken orally at 30 mg on days 1, 3, and 5 weekly within each cycle. This treatment will continue as first-line therapy for metastatic TNBC. The study will also assess secondary outcomes such as duration of response, progression-free survival, overall survival, and safety of the treatment. During the trial, participants will undergo regular assessments for tumor response using RECIST 1.1 criteria, organ function tests, and performance status evaluations. Researchers will monitor the overall response rate over 30 months, along with progression-free and overall survival. Safety and tolerability will be closely followed. The total participation duration depends on treatment response and survival, with ongoing monitoring throughout the study period.

Atezolizumab and Chemotherapy Treatment as T-cell Activators in Metastatic Triple Negative Breast Cancer Patients