Sac-TMT Plus KL-A167 in PD-L1+, HR+/HER2- Metastatic Breast Cancer After CDK4/6 Inhibitors

Recruiting Phase 2 Interventional Study
Breast Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
35 (estimated)
Sponsor
Sun Yat-sen University · Other
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About This Trial

This is a Phase II single-arm study designed to evaluate the efficacy and safety of Sac-TMT + KL-A167 in 35 patients with PD-L1+, HR+/HER2- metastatic breast cancer who previously treated with CDK4/6 inhibitor. The primary endpoint is the 6-month PFS rate. Treatment will continue until disease progression or intolerable toxicity, with periodic imaging assessments and survival follow-up.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. 18-75 years old. 2. HR+/HER2- breast cancer (BC), meeting the following conditions: 1. HR+/HER2-; HER2-(IHC 0 or 1+); IHC 2+(FISH negative); HR+ (ER and/or PR IHC showed ≥1%); 2. Tumor stage: Locally advanced, recurrent, or metastatic HR+/HER2- breast cancer; 3) Diseas…
Contacts

Fei Xu, MD

+86-13711277870

xufei@sysucc.org.cn

CONTACT

Kuikui Jiang, MD

+86-15210589011

jiangkk@sysucc.org.cn

CONTACT