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Atezolizumab Combined With Immunogenic Chemotherapy in Patients With Metastatic Triple-negative Breast Cancer — ALICE  

Triple Negative Breast Cancer Clinical Trial

Official title:
ALICE: A Randomized Placebo-controlled Phase II Study Evaluating Atezolizumab Combined With Immunogenic Chemotherapy in Patients With Metastatic Triple-negative Breast Cancer

Clinical Trial Summary

This is a randomized, double-blind, placebo-controlled phase II study evaluating the safety and efficacy of Atezolizumab when combined with immunogenic chemotherapy in subjects with metastatic triple-negative breast cancer. Atezolizumab, pegylated liposomal doxorubicin and cyclophosphamide are the Investigational Medicinal Products (IMPs).

Clinical Trial Description

Breast cancer is rarely curable after metastasis, and the therapeutic options for metastatic triple negative breast cancer (TNBC) are limited. The host immune response is strongly predictive for the effect of chemotherapy in patients with TNBC. In the present trial, we combine Atezolizumab, an inhibitory antibody against Programmed Death Ligand-1 (PD-L1), with chemotherapy. Thereby, we aim to release the brake on the chemo-induced immune response. The chemotherapeutic regime is a combination of anthracycline and cyclophosphamide, applied in a semi-metronomic fashion (pegylated liposomal doxorubicin every 2nd week and daily cyclophosphamide for 2/4 weeks). The investigators hypothesize that the semi-metronomic regime will induce immunological cell death and counter T regulatory cells, while maintaining the leukocyte counts and the ability of the effector immune cells to respond. The use of pegylated liposomal doxorubicin (Caelyx) minimizes the adverse effects of anthracyclines on the heart and allows for continued treatment beyond the otherwise mandatory anthracycline limits. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03164993
Study type Interventional
Source Oslo University Hospital
Contact
Status Completed
Phase Phase 2
Start date June 1, 2017
Completion date September 30, 2023
View Details
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