At a glance
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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
In Brief
A Phase 2 clinical trial evaluating Durvalumab, Capivasertib, and 4 other interventions for Triple Negative Breast Neoplasms. Active but no longer recruiting, targeting 243 participants across 32 sites in 6 countries.
Detailed 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
Study Details
Timeline
Interventions
Durvalumab iv Every 4 weeks (q4w) or 3 weeks (q3w) Arm 6, 7 and 8
Capivasertib oral bid 4-week cycles; 3 weeks on (dosing on days 2,3,4 and 5) and 1 week off
Oleclumab iv Every 2 weeks (q2w) for first 2 cycles (days 1 and 15 in cycles 1 and 2), then every 4 weeks (q4w) starting at cycle 3 day 1
Paclitaxel iv 4-week cycles: 3 weeks once weekly (q1w) and 1 week off
Trastuzumab deruxtecan iv 3-week cycles (once weekly) q3w
Datopotamab deruxtecan iv 3-week cycles (once weekly) q3w