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

Interested in this trial?

Print this page and take it to your doctor to discuss your eligibilty and treatment options. Only your doctor can refer you to a clinical trial.

Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society