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

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.

Inclusion criteria

1. Female

2. At least 18 years of age at the time of screening

3. Patient must have locally confirmed TNBC

4. No prior treatment for metastatic (Stage IV) TNBC

5. Patient must have at least 1 lesion, not previously irradiated, that can be accurately
measured

6. WHO/ECOG status at 0 or 1 at enrollment

Exclusion criteria

1. History of venous thromboembolism in the past 3 months

2. Diagnosis of diabetes mellitus Type I or diabetes mellitus Type II requiring insulin
treatment

3. History of allogeneic organ transplantation

4. Active or prior documented autoimmune or inflammatory disorders

5. 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)

6. Untreated CNS metastases

7. Known allergy or hypersensitivity to any of the study drugs or any of the study drug
excipients

8. Any concurrent chemotherapy, IP, or biologic therapy for cancer treatment

9. Female patients who are pregnant or breastfeeding