A Phase IB/II, 2-Stage, Open-label, Multicenter Study to Determine the Efficacy and Safety of Durvalumab (MEDI4736) + Paclitaxel and Durvalumab (MEDI4736) in Combination With Novel Oncology Therapies With or Without Paclitaxel for First-line Metastatic Triple Negative Breast Cancer (BEGONIA)

and human epidermal growth factor receptor 2., First-line (1L) Stage IV Triple Negative Breast Cancer (TNBC) - the subtype of breast cancer characterized by a lack of tumor expression of estrogen receptor, progesterone receptor

Part 1: AEs, exposure, physical examinations, laboratory findings, and vital signs, Part 2: Endpoints based on Investigator assessment according to RECIST 1.1: ORR (objective response rate): The percentage of evaluable patients with a confirmed Investigator-assessed visit response of CR (complete response) or PR (partial response).

Part 1: Endpoints based on Investigator assessment according to RECIST 1.1: ORR (objective response rate): The percentage of evaluable patients with a confirmed Investigator-assessed visit response of CR (complete response) or PR (partial response), Part 1: Endpoints based on Investigator assessment according to RECIST 1.1: PFS (progression-free survival): Time from date of first dose until the date of objective radiological disease progression using RECIST 1.1 or death (by any cause in the absence of progression, Part 1: Endpoints based on Investigator assessment according to RECIST 1.1: DoR (duration of response): Time from date of first detection of objective response (which is subsequently confirmed) until the date of objective radiological disease progression, Part 1: Endpoints based on Investigator assessment according to RECIST 1.1: OS (overall survival): Time from date of first dose until the date of death by any cause, Part 1: Serum concentration of durvalumab and serum or plasma concentration of novel oncology therapies, Part 1: Presence of ADAs for durvalumab and applicable novel oncology therapies, Part 2: Endpoints based on Investigator assessment according to RECIST 1.1: PFS (progression-free survival): Time from date of first dose until the date of objective radiological disease progression using RECIST 1.1 or death (by any cause in the absence of progression), Part 2: Endpoints based on Investigator assessment according to RECIST 1.1: DoR (duration of response): Time from date of first detection of objective response (which is subsequently confirmed) until the date of objective radiological disease progression, Part 2: Endpoints based on Investigator assessment according to RECIST 1.1: PFS6: PFS at 6 months following date of first dose, Part 2: Endpoints based on Investigator assessment according to RECIST 1.1: OS (overall survival): Time from date of first dose until the date of death by any cause, Part 2: AEs, exposure, physical examinations, laboratory findings, and vital signs

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