A Trial of SHR-A1811 Compared to Other Antitumor Therapies as Neoadjuvant Treatments in Early-stage or Locally Advanced HER2-positive Breast Cancer

This study is a multicenter, randomized, open-label, parallel Phase III clinical trial. 650 early-stage or locally advanced breast cancer participants will be enrolled and randomly assigned to SHR-A1811 monotherapy group (trial group) or TCbHP treatment group (control group) at a 1:1 ratio. Participants will receive neoadjuvant treatments of SHR-A1811 or TCbHP, while those who have completed neoadjuvant therapy and are suitable for surgery must undergo surgical treatment. The participants will be evaluated on tumor efficacy through postoperative pathological assessment by IRC and pathologists

Trial Details

NCT ID
NCT07196774
Phase
PHASE3
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Status
RECRUITING
Cancer Type
HER2 Positive Breast Cancer
Interventions
  • SHR-A1811 for Injection
  • Docetaxel injection
  • Trastuzumab Injection
  • Carboplatin for Injection
  • Pertuzumab Injection
Locations (sample)
  • Shenyang, Liaoning, China|41.79222,123.43278
  • Shanghai, Shanghai Municipality, China|31.22222,121.45806

Key Eligibility Criteria

  • Females treated for the first time, 18-75 years old;
  • ECOG score 0-1;
  • Has pathological diagnosis that meets the criteria: confirmed HER2 positive;
  • Results of laboratory tests meet the enrollment requirements;

For full eligibility, visit ClinicalTrials.gov.

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