Clinical Trial

A Study of SHR-A1811 as Neoadjuvant Treatment for Patients With HR-Positive, Low HER2 Expression Breast Cancer

Recruiting Phase 2
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Record status
This record was last updated November 4, 2024 (before its estimated December 31, 2024 completion). Its status may not reflect the trial's current state.
Summary
HR-positive breast cancers accounts for about 50% to 60% of all breast cancer patients. Neoadjuvant Chemotherapy is the core treatment mode for this type of breast cancer, and endocrine therapy can be used in some low-risk patients. However, the pathological complete response (pCR) rate obtained is low. HER2 is an important prognostic indicator and therapeutic target for breast cancer. Nearly 60% of HR-positive breast cancers have low expression of HER2, and antibody-drug conjugates (ADC) targeting HER2 may achieve better efficacy in this subtype.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2023-06-12; most recent amendment 2024-10-31.
Status change: Active, Not Recruiting → Recruiting 2023-12-18
Status change: Not Yet Recruiting → Active, Not Recruiting 2023-09-26
Trial Details
NCT Number NCT05911958
Lead Sponsor Henan Cancer Hospital
Conditions HER2 Low Breast Carcinoma
Enrollment 66 participants
Start Date 2023-07-05
Primary Completion 2024-12-31 (estimated)
Study Completion 2029-05-31 (estimated)
Updated on ClinicalTrials.gov 2024-11-04