drugset / Trial / NCT03853707

Ipatasertib in Combination With Carboplatin, Carboplatin/Paclitaxel, or Capecitabine/Atezolizumab in Treating Patients With Metastatic Triple Negative Breast Cancer

NCT03853707

RandomizedParallel-groupOpen-labelTreatment

Summary

This phase I trial studies best dose of ipatasertib and how well it works with carboplatin with or without paclitaxel in treating patients with triple negative breast cancer that has spread to other places in the body (metastatic). Ipatasertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin, paclitaxel, and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether giving ipatasertib in combination with carboplatin, carboplatin/paclitaxel, or capecitabine/atezolizumab will work better in treating patients with triple negative breast cancer.

Timeline

Start
2019-03-04
Primary completion
2023-01-21
Completion
2023-09-19

Drugs

EvaluationDrugModalityDoseRoute
Subject Atezolizumab Monoclonal antibody 840 mg Intravenous
Subject Capecitabine Small molecule 750 mg/m2 Oral
Subject Carboplatin Small molecule 2 unknown Intravenous
Subject Ipatasertib Small molecule 300 mg Oral
Subject Ipatasertib Small molecule 400 mg Oral
Subject Paclitaxel Small molecule 80 mg/m2 Intravenous