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Life sciences · Phase 2 Trial
ClinicalTrials.gov · October 2, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 2 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT07844018). This is a study registration, not published results. Lead sponsor: Peking University People's Hospital. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 88 participants (ESTIMATED). Conditions: Breast Cancer (Early Breast Cancer). Interventions: DRUG: HER2 target therapy. Primary outcome measures: pathology complete response rate , From enrollment to the end of treatment at 6 months. Brief summary: This study adopts a single-center, open-label, single-arm interventional design. It will enroll 88 patients with histologically confirmed HER2-positive early breast cancer who are suitable for surgery and neoadjuvant therapy, and stratify them by HER2 homogeneity/heterogeneity based on histological analysis. Subjects are not randomized and all will enter the intervention arm; patients with different HER2 homogeneity/heterogeneity will receive regimens based on anti-HER2 antibody-drug conjugates (ADCs). Recruitment is planned to commence in January 2027 and complete enrollment by December 2028. After obtaining fully informed consent and meeting eligibility criteria, eligible subjects will enter the trial phase and receive a regimen based on anti-HER2 ADCs. Once enrolled, subjects must receive the investigational drug within 72 hours. Each treatment cycle lasts 3 weeks, for a total of 8 cycles, and treatment will continue until the end of the course or until disease progression, unacceptable toxicity, death, withdrawal of informed consent, loss to follow-up, study completion, or study termination.