drugset / Trial / NCT03801369

AMTEC IIT: Phase 2 Multiarm Study in TNBC

NCT03801369

Non-randomizedParallel-groupOpen-labelTreatment

Summary

This phase II study assesses the efficacy of the combination of olaparib with durvalumab, selumetinib, or capivasertib or ceralasertib alone in the treatment of patients with metastatic triple negative breast cancer (TNBC). Olaparib may stop growth of tumor cells by inhibiting some of the enzymes (ADP ribose polymerase \[PARP\]) needed for cell growth. Durvalumab, a monoclonal antibody, inhibits the growth and spread of tumors by stimulating the patient's antitumor immune response. Selumetinib, capivasertib, and ceralasertib are inhibitor drugs that may stop the growth of tumor cells by blocking some of the enzymes (MEK, AKT, ATR) needed for cell growth. Giving olaparib together with durvalumab, selumetinib, or capivasertib or giving ceralasertib alone may provide an effective method to treat patients with metastatic triple negative breast cancer.

Timeline

Start
2018-12-12
Primary completion
2024-10-22
Completion
2024-12-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Capivasertib Small molecule Oral
Subject Ceralasertib Small molecule Oral
Subject Durvalumab Monoclonal antibody Intravenous
Subject Olaparib Small molecule Oral
Subject Selumetinib Small molecule Oral