A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer.

Official Title

A Phase IB/II, 2-stage, Open-label, Multicentre Study to Determine the Efficacy and Safety of Durvalumab (MEDI4736) in Combination With Paclitaxel and Multiple Novel Oncology Therapies and Durvalumab (MEDI4736) + Paclitaxel for First-line Metastatic Triple Negative Breast Cancer.

Summary:

This study is designed to determine the efficacy and safety of durvalumab in combination with paclitaxel and multiple novel oncology therapies and durvalumab with paclitaxel alone for the treatment of first-line metastatic triple negative breast cancer.

Trial Description

Primary Outcome:

• Incidence of adverse events
• Laboratory findings

Secondary Outcome:

• Objective response rate (ORR)
• Progression-free survival (PFS).
• Duration of response (DoR)
• Overall survival (OS)
• Blood concentration of durvalumab and novel oncology therapies
• Presence of anti-drug antibodies (ADAs) for durvalumab and applicable novel oncology therapies

This is a Phase IB/II, 2-stage, open-label, multicentre study to determine the efficacy and safety of durvalumab + paclitaxel + novel oncology therapies (i.e. therapies designed for immune modulation) and durvalumab + paclitaxel alone as first-line treatment in patients with metastatic triple negative breast cancer (TNBC). The study is designed to concurrently evaluate potential novel triplet combinations with clinical promise using a 2-stage approach. Part 1 is a Phase IB study of safety and initial efficacy, and Part 2 is a Phase II study. The triplet treatment regimens evaluated in Part 2 will depend on the evaluation of safety and efficacy outcomes in Part 1.

View this trial on ClinicalTrials.gov