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

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.

Inclusion Criteria

• Female
• At least 18 years of age at the time of screening
• Patient must have locally confirmed TNBC
• No prior treatment for metastatic (Stage IV) TNBC
• Patient must have at least 1 lesion, not previously irradiated, that can be accurately measured
• WHO/ECOG status at 0 or 1 at enrollment

Exclusion Criteria

• History of venous thromboembolism in the past 3 months
• Diagnosis of diabetes mellitus Type I or diabetes mellitus Type II requiring insulin treatment
• History of allogeneic organ transplantation
• Active or prior documented autoimmune or inflammatory disorders
• Active infection including tuberculosis, hepatitis B (known positive HBV surface antigen [HBsAg] result), hepatitis C virus (HCV), or human immunodeficiency virus (positive HIV 1/2 antibodies)
• Untreated CNS metastases
• Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients
• Any concurrent chemotherapy, IP, or biologic therapy for cancer treatment
• Female patients who are pregnant or breastfeeding

This is a Phase IB/II, 2-stage, open-label, multicenter 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.

Lead Organization
AstraZeneca Pharmaceuticals LP

Primary ID D933LC00001
Secondary IDs NCI-2019-05878, 2018-000764-29
Clinicaltrials.gov ID NCT03742102