A Phase 1b/2 Study of T-DXd Combinations in HER2-positive Metastatic Breast Cancer

Official Title

A Phase 1b/2 Multicentre, Open-label, Modular, Dose-finding and Dose-expansion Study to Explore the Safety, Tolerability, and Anti-tumour Activity of Trastuzumab Deruxtecan (T-DXd) in Combination With Other Anti-cancer Agents in Patients With HER2-positive Metastatic Breast Cancer (DESTINY-Breast07)

Summary:

DESTINY-Breast07 will investigate the safety, tolerability, and anti-tumour activity of trastuzumab deruxtecan (T-DXd) in combination with other anti-cancer agents in patients with HER2-positive Metastatic Breast Cancer

Trial Description

Primary Outcome:

• Occurrence of adverse events (AEs)- Part 1
• Occurrence of serious adverse events (SAEs)- Part 1
• Occurrence of adverse events (AEs)- Part 2
• Occurrence of serious adverse events (SAEs)- Part 2

Secondary Outcome:

• Objective Response Rate (ORR)- Part 2
• Progression Free Survival (PFS)- Part 2
• Progression Free Survival 2 (PFS2)- Part 2
• Duration of Response (DoR)- Part 2
• Overall Survival (OS)- Part 2
• Serum Concentration of Trastuzumab Deruxtecan (T-DXd)
• Serum Concentration of Durvalumab
• Serum Concentration of Pertuzumab
• Plasma Concentration of Paclitaxel
• Plasma Concentration of Tucatinib
• Immunogenicity of trastuzumab deruxtecan
• Immunogenicity of Durvalumab
• Immunogenicity of Pertuzumab

This study is modular in design allowing assessment of safety, tolerability and anti-tumour activity of T-DXd in combination with other anti-cancer agents. Combination-treatment modules will have 2 parts: a dose-finding phase (Part 1), and a dose expansion phase (Part 2); the recommended Phase 2 dose (RP2D) determined in Part 1 will be used for the dose-expansion in Part 2.

The target population of interest in this study is patients with HER2-positive (as per ASCO/CAP 2018 guidelines) advanced/MBC inclusive of patients with active and stable brain metastases. Part 1 of each module will enroll patients with locally assessed HER2-positive advanced/MBC in second-line or later patients. Part 2 of each module will enroll patients with locally assessed HER2-positive breast cancer who have not received prior treatment for advanced/metastatic disease.

View this trial on ClinicalTrials.gov