Study identifier:D933LC00001
ClinicalTrials.gov identifier:NCT03742102
EudraCT identifier:2018-000764-29
CTIS identifier:N/A
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
Triple Negative Breast Neoplasms
Phase 1/2
No
Durvalumab, Capivasertib, Oleclumab, Paclitaxel, Trastuzumab deruxtecan, Datopotamab deruxtecan
Female
243
Interventional
18 Years - 130 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Aug 2024 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Arm 1 durvalumab + paclitaxel | Drug: Durvalumab Durvalumab iv Every 4 weeks (q4w) or 3 weeks (q3w) Arm 6, 7 and 8 Other Name: MEDI4736 Drug: Paclitaxel Paclitaxel iv 4-week cycles: 3 weeks once weekly (q1w) and 1 week off |
Experimental: Arm 2 durvalumab + paclitaxel + capivasertib | Drug: Durvalumab Durvalumab iv Every 4 weeks (q4w) or 3 weeks (q3w) Arm 6, 7 and 8 Other Name: MEDI4736 Drug: Capivasertib Capivasertib oral bid 4-week cycles; 3 weeks on (dosing on days 2,3,4 and 5) and 1 week off Other Name: AZD5363 Drug: Paclitaxel Paclitaxel iv 4-week cycles: 3 weeks once weekly (q1w) and 1 week off |
Experimental: Arm 5 durvalumab + paclitaxel + oleclumab | Drug: Durvalumab Durvalumab iv Every 4 weeks (q4w) or 3 weeks (q3w) Arm 6, 7 and 8 Other Name: MEDI4736 Drug: Oleclumab 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 Other Name: MEDI9447 Drug: Paclitaxel Paclitaxel iv 4-week cycles: 3 weeks once weekly (q1w) and 1 week off |
Experimental: Arm 6 durvalumab + trastuzumab deruxtecan | Drug: Durvalumab Durvalumab iv Every 4 weeks (q4w) or 3 weeks (q3w) Arm 6, 7 and 8 Other Name: MEDI4736 Drug: Trastuzumab deruxtecan Trastuzumab deruxtecan iv 3-week cycles (once weekly) q3w Other Name: DS-8201a |
Experimental: Arm 7 durvalumab + datopotamab deruxtecan | Drug: Durvalumab Durvalumab iv Every 4 weeks (q4w) or 3 weeks (q3w) Arm 6, 7 and 8 Other Name: MEDI4736 Drug: Datopotamab deruxtecan Datopotamab deruxtecan iv 3-week cycles (once weekly) q3w Other Name: Dato-DXd; DS-1062a |
Experimental: Arm 8 durvalumab + datopotomab deruxtecan (patients with PD-L1 positive status) | Drug: Durvalumab Durvalumab iv Every 4 weeks (q4w) or 3 weeks (q3w) Arm 6, 7 and 8 Other Name: MEDI4736 Drug: Datopotamab deruxtecan Datopotamab deruxtecan iv 3-week cycles (once weekly) q3w Other Name: Dato-DXd; DS-1062a |