NCT04556773

A Phase 1b Study of T-DXd Combinations in HER2-low Advanced or Metastatic Breast Cancer

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)

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 138 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

DESTINY-Breast 08 will investigate the safety, tolerability, PK and preliminary anti-tumour activity of T-DXd in combination with other therapies in patients with Metastatic HER2-low Advanced or Metastatic Breast Cancer

Detailed description

This study is modular in design allowing assessment of the safety, tolerability, PK and preliminary anti-tumour activity of T-DXd in combination with other therapies. Combination-treatment modules 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 RP2D determined in Part 1. The target population of interest in this study is patients with HER2-low (IHC 1+ or IHC 2+/ISH -) (as per ASCO/CAP 2018 guidelines) advanced/MBC. Part 1 of each module will enroll patients with locally confirmed HER2-low advanced/MBC in second-line or later (≥ 2L) settings Part 2 of each module will enroll patients with HER2-low MBC who have either not received prior treatment, or received only 1 prior treatment (depending on the module-specific exclusion criteria) 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	Capivasertib	Capivasertib: administered orally
DRUG	Anastrozole	Anastrozole: administered orally
DRUG	Fulvestrant	Fulvestrant: administered as an IM injection
DRUG	Capecitabine	Capecitabine: administered orally

Timeline

• Start date: 2020-12-17
• Primary completion: 2023-08-16
• Completion: 2026-06-16
• First posted: 2020-09-21
• Last updated: 2025-12-17

Locations

37 sites across 10 countries: United States, Australia, Belgium, Brazil, Canada, France, Mexico, Russia, South Korea, Taiwan

Regulatory

• FDA-regulated drug study