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

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.

Timeline

Start

2017-12-15

Primary completion

2021-03-31

Completion

2022-06-30

Outcome

Met primary endpoint

registry analysis (superiority test); (Vic-)Trastuzumab Duocarmazine vs Physician's Choice; p =0.002; Hazard Ratio (HR) 0.6401 (95% CI 0.4885 to 0.8389) NCT03262935 ↗

paper T-Duo significantly reduced the risk of progression in patients with advanced HER2+ breast cancer who have progressed during/after ≥2 HER2-targeted therapies or after T-DM1. PMID 39442070 ↗

release “The Phase III TULIP study “SYD985 vs. Physician's Choice in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer” met its primary endpoint” byondis.com ↗

Publications

• Turner N, Saura C, Aftimos P, van den Tweel E, Oesterholt M, Koper N, Colleoni M, Kaczmarek E, Punie K, Song X, Armstrong A, Bianchi G, Stradella A, Ladoire S, Lim JSJ, Quenel-Tueux N, Tan TJ, Escriva-de-Romani S, O'Shaughnessy J; TULIP Trial Investigators. Trastuzumab Duocarmazine in Pretreated Human Epidermal Growth Factor Receptor 2-Positive Advanced or Metastatic Breast Cancer: An Open-Label, Randomized, Phase III Trial (TULIP). J Clin Oncol. 2025 Feb 10;43(5):513-523. doi: 10.1200/JCO.24.00529. Epub 2024 Oct 23.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Capecitabine	Small molecule	—	—
Comparator	Eribulin	Small molecule	—	—
Comparator	Lapatinib	Small molecule	—	—
Comparator	Trastuzumab	Monoclonal antibody	—	—
Subject	Trastuzumab duocarmazine	Other / unclassified	—	Intravenous
Comparator	Vinorelbine	Small molecule	—	—

Indications