OncoMatch/Clinical Trials/NCT07647263
Trastuzumab Rezetecan Neoadjuvant Therapy in THP-Insensitive HER2-Positive Early Breast Cancer
Is NCT07647263 recruiting? Yes, currently enrolling (Jul 2026). This Phase 2 trial studies multiple treatments including THP Regimen (Taxane + Trastuzumab + Pertuzumab) and Trastuzumab Rezetecan (SHR-A1811) for her2-positive breast cancer.
Treatment: THP Regimen (Taxane + Trastuzumab + Pertuzumab) · Trastuzumab Rezetecan (SHR-A1811) — 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 (\<80% tumor cell killing for HER2+/HR- tumors; \<60% for HER2+/HR+ tumors). These non-responders will switch to receive 4 cycles of trastuzumab rezetecan (SHR-A1811), a novel HER2-targeted antibody-drug conjugate (ADC). Patients with a favorable response (≥50% tumor reduction or meeting the PDO threshold) will continue with an additional 4 cycles of THP. The primary objective is to evaluate the pathologic complete response (pCR) rate in THP non-responders after switching to trastuzumab rezetecan. Secondary objectives include objective response rate (ORR), event-free survival (EFS), overall survival (OS), 3-year invasive disease-free survival (iDFS), and safety profiles of both treatment strategies. Outcomes in patients who continue THP will be described for exploratory purposes. A total of 124 patients will be enrolled. This response-adapted, individualized strategy aims to provide an effective option for HER2-positive breast cancer patients with an inadequate early response to conventional THP neoadjuvant therapy.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) overexpression (ihc 3+ or ihc 2+ with fish amplification)
Disease stage
Required: Stage II, III
Excluded: Stage IV
Performance status
ECOG 0–1(Restricted strenuous activity)
ECOG performance status 0 or 1
Demographics
Prior therapy
Cannot have received: chemotherapy for breast cancer
No prior chemotherapy ... for breast cancer
Cannot have received: immunotherapy for breast cancer
No prior ... immunotherapy ... for breast cancer
Cannot have received: endocrine therapy for breast cancer
No prior ... endocrine therapy ... for breast cancer
Cannot have received: radiotherapy for breast cancer
No prior ... radiotherapy for breast cancer
Cannot have received: radical surgery for breast cancer
No prior ... radical surgery ... for breast cancer
Cannot have received: HER2-targeted monoclonal antibody
current or prior use of HER2-targeted monoclonal antibodies
Cannot have received: HER2-targeted antibody-drug conjugate
current or prior use of HER2-targeted antibody-drug conjugates (ADCs)
Cannot have received: HER2 tyrosine kinase inhibitor
current or prior use of ... tyrosine kinase inhibitors (TKIs)
Lab requirements
Blood counts
Hemoglobin ≥90 g/L; white blood cell count ≥3.5×10⁹/L; platelet count ≥100×10⁹/L; neutrophil count ≥1.5×10⁹/L
Kidney function
Serum creatinine ≤1.5×ULN
Liver function
AST or ALT ≤3× ULN; total bilirubin ≤1.5×ULN
Cardiac function
No evidence of myocardial ischemia on ECG; NYHA class I; LVEF ≥55%; cardiac troponin I and BNP within normal limits
Adequate organ function as evidenced by the following laboratory values: Hemoglobin ≥90 g/L, WBC ≥3.5×10⁹/L, Platelet count ≥100×10⁹/L, Neutrophil count ≥1.5×10⁹/L, AST or ALT ≤3× ULN, Total bilirubin ≤1.5×ULN, Serum creatinine ≤1.5×ULN. No evidence of myocardial ischemia on ECG; NYHA class I; LVEF ≥55%; cardiac troponin I and BNP within normal limits.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07647263 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require ERBB2?
Yes, ERBB2 overexpression is a required biomarker for enrollment.
What disease stage is eligible?
Stage II or III is required.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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