NCT04538742

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

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)

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 245 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

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.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Trastuzumab deruxtecan	T-DXd: administered as an IV infusion
DRUG	Durvalumab	Durvalumab: administered as an IV infusion
DRUG	Paclitaxel	Paclitaxel: administered as an IV infusion
DRUG	Pertuzumab	Pertuzumab: administered as an IV infusion
DRUG	Tucatinib	Tucatinib administered orally (tablet) twice daily

Timeline

• Start date: 2020-12-28
• Primary completion: 2025-01-31
• Completion: 2030-01-31
• First posted: 2020-09-04
• Last updated: 2025-12-08

Locations

72 sites across 15 countries: United States, Australia, Brazil, Canada, France, Germany, India, Italy, Poland, Russia, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study