NCT03742102

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

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

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 243 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: Female
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Triple Negative Breast Neoplasms

Interventions

Type	Name	Description
DRUG	Durvalumab	Durvalumab iv Every 4 weeks (q4w) or 3 weeks (q3w) Arm 6, 7 and 8
DRUG	Capivasertib	Capivasertib oral bid 4-week cycles; 3 weeks on (dosing on days 2,3,4 and 5) and 1 week off
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
DRUG	Paclitaxel	Paclitaxel iv 4-week cycles: 3 weeks once weekly (q1w) and 1 week off
DRUG	Trastuzumab deruxtecan	Trastuzumab deruxtecan iv 3-week cycles (once weekly) q3w
DRUG	Datopotamab deruxtecan	Datopotamab deruxtecan iv 3-week cycles (once weekly) q3w

Timeline

• Start date: 2018-12-21
• Primary completion: 2024-11-29
• Completion: 2027-02-26
• First posted: 2018-11-15
• Last updated: 2026-02-02
• Results posted: 2026-02-02

Locations

32 sites across 6 countries: United States, Canada, Poland, South Korea, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study