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

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.

Trial Details

NCT ID
NCT05911958
Phase
PHASE2
Sponsor
Henan Cancer Hospital
Status
RECRUITING
Cancer Type
HER2 Positive Breast Cancer
Interventions
  • SHR-A1811 for injection
Locations (sample)
  • Zhengzhou, Henan, China|34.75778,113.64861

Key Eligibility Criteria

  • Patients aged 18 to 70 years old (inclusive);
  • Treatment-naive patients with clinically confirmed T2-T3, any nodal status and M0;
  • HR-positive, HER2 low expression, the expression of Ki-67 exceed 14% invasive breast cancer confirmed by histology or cytology;
  • ECOG performance status of 0-1;

For full eligibility, visit ClinicalTrials.gov.

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