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AstraZeneca D933LC00001 (BEGONIA): A phase IB/II, two-stage, open-label, multicenter study to determine the efficacy and safety of durvalumab (MEDI4736) in combination with paclitaxel and multiple, novel oncology therapies and durvalumab (MEDI4736) plus paclitaxel for first-line, metastatic, triple-negative breast cancer (TNBC)

Description

This is a Phase IB/II, two-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 two-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.

Status

Accepting new patients

Primary Study Objective(s)

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.

Core eligibility

Note: This is only a partial list of eligibility criteria.

Including patients who:

  • Are females at least 18 years old at the time of screening
  • Have locally confirmed TNBC
  • Have no prior treatment for metastatic (stage IV) TNBC
  • Have at least one lesion, not previously irradiated, that can be accurately measured
  • Have WHO/ECOG status at 0 or 1 at enrollment

Excluding patients who:

  • Have a history of venous thromboembolism in the past three months
  • Have a diagnosis of diabetes mellitus Type I or diabetes mellitus Type II requiring insulin treatment
  • Have had an allogeneic organ transplantation
  • Have active or prior documented autoimmune or inflammatory disorders
  • Have an 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)
  • Have untreated CNS metastases
  • Have known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients
  • Have any concurrent chemotherapy, IP, or biologic therapy for cancer treatment
  • Are pregnant or breastfeeding
     

Accepting new patients

 

Learn more at

clinicaltrials.gov

 

Principal Investigator(s)

Sramila Aithal

Cynthia Lynch