Anlotinib With Trastuzumab Deruxtecan for Previously Treated HER2-Low Advanced Breast Cancer

Recruiting Phase 1 Interventional Study
Breast Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 75
Sex
Female
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
42 (estimated)
Sponsor
Fudan University · Other
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About This Trial

This study will evaluate the safety, tolerability and efficacy of anlotinib and trastuzumab deruxtecan in human epidermal growth factor receptor 2 (HER2)-low unresectable and/or metastatic breast cancer who had received ≤1 line of prior chemotherapy.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 1\. Age 18 - 75 years; ECOG PS 0 or 1. 2. Pathologically documented breast cancer that: 1. Is unresectable or metastatic. 2. Has a history of low HER2 expression (IHC 1+\& IHC 2+/ISH- or 0\<IHC\<1+). 3. Is HR-positive or HR-negative. 4. Has progressed on, and would no…
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