Testing Two Different Drugs (Sacituzumab-govitecan and Trastuzumab-deruxtecan) Combinations Prescribed in an Alterning Pattern to Patients With Metastatic or Locally Advanced Triple-negative Breast Cancer

This is a phase II, multicentre, open-label, randomised controlled trial (patients are randomly assigned to one treatment arm or the other) evaluating two treatment strategies (sacituzumab govitecan and trastuzumab deruxtecan in an alternative schema or sacituzumab govitecan alone) in patients with locally advanced or metastatic triple-negative breast cancer. The goal is to answer the question: Does alternating sacituzumab goveitecan (SG) and trastuzumab deruxtecan (T-DXd) improve survival in patients with HER2-low metastatic triple-negative breast cancer compared to continuing treatment with SG alone?

NCT Number	NCT07151586
Lead Sponsor	UNICANCER
Conditions	Triple Negative Breast Neoplasms, Neoplasm Metastasis, HER 2 Low-expressing Breast Cancer
Enrollment	260 participants
Start Date	2026-09
Primary Completion	2029-10 (estimated)
Study Completion	2029-10 (estimated)
Updated on ClinicalTrials.gov	2026-08-03