Trial Identifiers
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Scientific Title
A Phase 1b Multicentre, Open-label, Modular, Dose-finding and Dose-expansion Study to Explore the Safety, Tolerability, Pharmacokinetics and Anti-tumour Activity of Trastuzumab Deruxtecan (T-DXd) in Combination With Other Anti-cancer Agents in Patients With Metastatic HER2-low Breast Cancer (DESTINY-Breast08)
Commercial Sponsor
AstraZeneca
Summary
This is a non-randomised study initially consisting of 5 treatment modules, each of which includes T-DXd (Trastuzumab deruxtecan) in combination with other anti-cancer agents. Each module will have 2 parts: a dose-finding phase (Part 1) and a dose-expansion phase (Part 2). The Part 2 dose-expansion phase will use the recommended Phase 2 dose (RP2D) for the combination, either as determined in Part 1 or from another clinical study if appropriate. For each module, patients will be centrally assigned to one of the open modules, as per the module specific criteria. In Module 1, participants will receive T-DXd (administered intravenously, 5.4 mg/kg Q3W) in combination with Capecitabine (administered orally, 100mg/m2 BID, days 1-14 Q3W). In Module 2, participants will receive T-DXd (administered orally, 5.4 mg/kg Q3W) in combination with Durvalumab (administered intravenously, 1120mg Q3W) and paclitaxel (administered intravenously, 90mg/m2 QW in 3-week cycles). In Module 3, participants will receive T-DXd (administered intravenously, 5.4mg/kg Q3W) in combination with capivasertib (administered orally, 400mg BID). In Module 4, participants will receive T-DXd (administered intravenously, 5.4mg/kg Q3W) in combination with Anastrozole (administered orally, 1mg daily). In Module 5, participants will receive T-DXd (administered intravenously, 5.4mg/kg Q3W) in combination with Fulvestrant (administered as an intramuscular injection, 500mg Q4W).