NCT03262935

SYD985 vs. Physician's Choice in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer

A Multi-centre, Open-label, Randomized Clinical Trial Comparing the Efficacy and Safety of the Antibody-drug Conjugate SYD985 to Physician's Choice in Patients With HER2-positive Unresectable Locally Advanced or Metastatic Breast Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 437 (actual)
• Sponsor: Byondis B.V. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to demonstrate that SYD985 \[(vic-)trastuzumab duocarmazine\] is superior to physician's choice in prolonging progression free survival.

Detailed description

This study is designed as a randomized, active-controlled, superiority study in patients with unresectable locally advanced or metastatic HER2-positive breast cancer. The patients should have had either progression during or after at least two HER2-targeting treatment regimens for locally advanced or metastatic disease or progression during or after (ado-)trastuzumab emtansine treatment. Eligible patients will be randomly assigned (2:1) to receive SYD985 or physician's choice treatment until disease progression, unacceptable toxicity or study termination by the Sponsor. During treatment, patients will have to visit the clinical site to assess efficacy, quality of life (QoL), and safety using standardized criteria.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	(vic-)trastuzumab duocarmazine	Intravenous SYD985, Q3W
DRUG	Physician's choice	See drug label

Timeline

• Start date: 2017-12-15
• Primary completion: 2021-03-31
• Completion: 2022-06-30
• First posted: 2017-08-25
• Last updated: 2023-10-19
• Results posted: 2023-10-19

Locations

90 sites across 11 countries: United States, Belgium, Canada, Denmark, France, Italy, Netherlands, Singapore, Spain, Sweden, United Kingdom

Regulatory

• FDA-regulated drug study