Trastuzumab Rezetecan Neoadjuvant Therapy in THP-Insensitive HER2-Positive Early Breast Cancer

This study is a response-adapted, multicenter, interventional trial enrolling patients with HER2-positive early or locally advanced breast cancer. All enrolled patients will first receive 2 cycles of standard neoadjuvant THP regimen, consisting of a taxane, trastuzumab, and pertuzumab. After the initial 2-cycle treatment, tumor response will be evaluated by radiologic imaging and patient-derived organoid (PDO) drug sensitivity testing. Patients with an inadequate response to THP are defined as those with \<50% tumor size reduction on imaging, or failure to reach the PDO sensitivity threshold

Trial Details

NCT ID
NCT07647263
Phase
PHASE2
Sponsor
The First Affiliated Hospital of Soochow University
Status
RECRUITING
Cancer Type
Ductal Carcinoma In Situ (DCIS) Breast Cancer
Interventions
  • THP Regimen (Taxane + Trastuzumab + Pertuzumab)
  • Trastuzumab Rezetecan (SHR-A1811)
Locations (sample)
  • Suzhou, Jiangsu, China|31.30408,120.59538

Key Eligibility Criteria

  • Age ≥18 years. For premenopausal and perimenopausal patients, a negative pregnancy test is required, and the patient must agree to use effective co…
  • Pathologically confirmed invasive breast cancer, stage II-III according to the 8th edition of the American Joint Committee on Cancer (AJCC) TNM sta…
  • At least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.
  • No prior chemotherapy, immunotherapy, endocrine therapy, radical surgery, or radiotherapy for breast cancer.

For full eligibility, visit ClinicalTrials.gov.

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