A Study to Evaluate the Safety and Efficacy of Ipatasertib in Combination With Atezolizumab and Paclitaxel or Nab-Paclitaxel in Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer

Summary

This is a study consisting of four cohorts in this setting. In Cohort 1, the safety and efficacy of ipatasertib (ipat) in combination with atezolizumab (atezo) and paclitaxel (pac) or nab-paclitaxel will be evaluated for participants with locally advanced or metastatic triple-negative breast cancer (TNBC) who have not previously received chemotherapy. In Cohort 2, ipatasertib and atezolizumab (with no chemotherapy), will be administered to participants with locally advanced or metastatic TNBC. In Cohort 3, the safety and efficacy of neoadjuvant ipatasertib, atezolizumab, doxorubicin and cyclophosphamide (AC) (Ipat + Atezo + AC) followed by Ipat + Atezo + Pac will be evaluated in participants with locally advanced Type 2-4 (T2-4) TNBC. In Cohort 4, the safety and efficacy of Ipat + Atezo + Pac will be evaluated in participants with PD-L1 (Programmed Death-Ligand-1) positive locally advanced or metastatic TNBC that is not amenable to resection and who have not previously received chemotherapy in the advanced setting.

Timeline

Start

2018-02-13

Primary completion

2022-03-16

Completion

2022-03-16

Publications

• Schmid P, Turner NC, Barrios CH, Isakoff SJ, Kim SB, Sablin MP, Saji S, Savas P, Vidal GA, Oliveira M, O'Shaughnessy J, Italiano A, Espinosa E, Boni V, White S, Rojas B, Freitas-Junior R, Chae Y, Bondarenko I, Lee J, Torres Mattos C, Martinez Rodriguez JL, Lam LH, Jones S, Reilly SJ, Huang X, Shah K, Dent R. First-Line Ipatasertib, Atezolizumab, and Taxane Triplet for Metastatic Triple-Negative Breast Cancer: Clinical and Biomarker Results. Clin Cancer Res. 2024 Feb 16;30(4):767-778. doi: 10.1158/1078-0432.CCR-23-2084.

Drugs

Indications