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

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).

Timeline

Start

2017-06-01

Primary completion

2023-04-25

Completion

2023-09-30

Publications

• Results Rossevold AH, Andresen NK, Bjerre CA, Gilje B, Jakobsen EH, Raj SX, Falk RS, Russnes HG, Jahr T, Mathiesen RR, Lomo J, Garred O, Chauhan SK, Lereim RR, Dunn C, Naume B, Kyte JA. Atezolizumab plus anthracycline-based chemotherapy in metastatic triple-negative breast cancer: the randomized, double-blind phase 2b ALICE trial. Nat Med. 2022 Dec;28(12):2573-2583. doi: 10.1038/s41591-022-02126-1. Epub 2022 Dec 8.
• Svalheim KG, Andresen NK, Bjerre C, Gilje B, Jakobsen EH, Falk RS, Naume B, Kaasa S, Kyte JA. Patient-reported outcomes from the randomized ALICE trial evaluating the addition of atezolizumab to anthracycline-based chemotherapy in metastatic triple-negative breast cancer. Breast. 2026 Apr;86:104704. doi: 10.1016/j.breast.2026.104704. Epub 2026 Jan 19.
• Kyte JA, Rossevold A, Falk RS, Naume B. ALICE: a randomized placebo-controlled phase II study evaluating atezolizumab combined with immunogenic chemotherapy in patients with metastatic triple-negative breast cancer. J Transl Med. 2020 Jun 23;18(1):252. doi: 10.1186/s12967-020-02424-7.

Drugs

Indications