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
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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