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 (Jun 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
Treatments studied
Targeted therapy
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)
Demographics
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.
Frequently asked questions
Is NCT05292742 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anti-tumor therapy or radiotherapy for any malignancy, anti-tumor therapy, anti-tumor therapy disqualifies patients from enrollment.
Does this trial require ERBB2?
Yes, ERBB2 overexpression is a required biomarker for enrollment.
What disease stage is eligible?
Stage CT1-4 or N0-3 is required.
Is there an age limit?
Yes. Patients must be 75 years or younger.
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.
Check if I qualifyRelated pages