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

  • STATUS
    Not Recruiting
  • End date
    Feb 13, 2023
  • participants needed
    203
  • sponsor
    AstraZeneca
Updated on 20 July 2022
paclitaxel
cancer
breast cancer
HER2
trastuzumab
antineoplastic
triple negative breast cancer
erbb2

Summary

This study is designed to determine the efficacy and safety of durvalumab in combination with novel oncology therapies with or without paclitaxel and durvalumab + paclitaxel for first-line metastatic triple negative breast cancer

Description

This is a Phase IB/II, 2-stage, open-label, multicenter study to determine the efficacy and safety of durvalumab in combination with novel oncology therapies (i.e. therapies designed for immune modulation) with or without paclitaxel and durvalumab + paclitaxel as first-line treatment in patients with metastatic triple negative breast cancer (TNBC). The study is designed to concurrently evaluate potential novel treatment combinations with clinical promise using a 2-stage approach. The study will use a Simon 2-Stage design to evaluate which cohorts may proceed to expansion.

Part 1 is a Phase IB study of safety and initial efficacy, and Part 2 may expand patient enrollment if adequate efficacy signal is observed in Part 1. The treatment regimens evaluated in Part 2 will depend on the evaluation of safety and efficacy outcomes in Part 1.

Details
Condition Triple Negative Breast Neoplasms
Treatment Selumetinib, Paclitaxel, durvalumab, Capivasertib, oleclumab, Trastuzumab deruxtecan, Danvatirsen, Datopotamab deruxtecan
Clinical Study IdentifierNCT03742102
SponsorAstraZeneca
Last Modified on20 July 2022

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