OncoMatch/Clinical Trials/NCT05292742
Compare Continuation of Original Targeted Therapy With Trastuzumab Combined With Pyrotinib and Capecitabine as Postoperative Adjuvant Therapy in Non-pCR Patients With HER2 Positive Early Breast Cancer
Is NCT05292742 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Pyrotinib+Trastuzumab+Capecitabine and Trastuzumab+Pertuzumab/Trastuzumab for breast cancer.
Treatment: Pyrotinib+Trastuzumab+Capecitabine · Trastuzumab+Pertuzumab/Trastuzumab — To evaluate the efficacy of continuation targeted therapy compared with trastuzumab combined with Pyrotinib and capecitabine in postoperative adjuvant therapy of HER-2 positive early breast cancer patients with residual tumor (primary breast tumor/axillary lymph nodes) who did not achieve pCR after neoadjuvant therapy
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) overexpression (> 10% immunoreactive cells with IHC score of 3+ or ISH results of HER2 gene amplification)
Pathologically confirmed HER2-expressing positive breast cancer, defined as > 10% immunoreactive cells with immunohistochemical (IHC) score of 3 + or in situ hybridization (ISH) results of HER2 gene amplification
Disease stage
Required: Stage CT1-4, N0-3
Excluded: Stage IV
primary tumor stage determined by standard evaluation methods：cT1-4/N0-3/M0; Stage IV (metastatic) breast cancer [excluded]
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: HER2-targeted therapy (trastuzumab) — neoadjuvant
at least 9 weeks of trastuzumab treatment
Must have received: taxane — neoadjuvant
at least 9 weeks of taxane chemotherapy
Cannot have received: anti-tumor therapy or radiotherapy for any malignancy
Exception: excluding cured cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma
Previous anti-tumor therapy or radiotherapy for any malignancy, excluding cured cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma
Cannot have received: anti-tumor therapy
Exception: except radiotherapy and endocrine therapy during treatment
Receiving anti-tumor therapy in other clinical trials, including bisphosphonate therapy or immunotherapy (except radiotherapy and endocrine therapy during treatment)
Cannot have received: anti-tumor therapy
Receiving any anti-tumor therapy within 28 days before enrollment
Cannot have received: anti-HER2 tyrosine kinase inhibitor (pyrrolidone)
Receiving pyrrolidone or other anti-HER2 tyrosine kinase inhibitors
Cannot have received: anthracycline (adriamycin, epirubicin)
Exception: adriamycin > 240 mg/m2, epirubicin > 480 mg/m2
Receiving anthracycline therapy with cumulative doses as follows: adriamycin > 240 mg/m2, epirubicin > 480 mg/m2
Lab requirements
Blood counts
anc ≥ 1.5 x 10^9/l; platelet count ≥ 90 x 10^9/l; hemoglobin ≥ 9.0 g/dl
Kidney function
bun and creatine clearance rate ≥ 50 ml/min
Liver function
total bilirubin ≤ 1.5 x uln; alt and ast ≤ 1.5 x uln
Cardiac function
lvef ≥ 55%; qtcf < 470 ms
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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