OncoMatch/Clinical Trials/NCT07797218
Neoadjuvant Pyrotinib-to-pertuzumab in HER2+ eBC
Is NCT07797218 recruiting? Yes, currently enrolling (Sep 2026). This Phase 3 trial studies multiple treatments including Docetaxel and Pyrotinib for breast cancer early stage breast cancer (stage 1-3).
Treatment: Docetaxel · Pyrotinib · Trastuzumab (Herceptin) · Pertuzumab — This is a randomized, open-label, superiority, multicenter clinical trial for patients with early or locally advanced (T≥2cm, N0-3, M0) HER2-positive breast cancer. It aims to compare the efficacy of neoadjuvant treatment with 2 cycles of Pyrotinib + Trastuzumab + Docetaxel followed by 2 cycles of Pertuzumab + Trastuzumab + Docetaxel versus 4 cycles of Pertuzumab + Trastuzumab + Docetaxel. Exploratory analyses of ctDNA clearance rate and MRI response will also be conducted.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Chemotherapy
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) overexpression (ihc 3+ or ish amplification)
Disease stage
Required: Stage II, III
Excluded: Stage IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: cytotoxic chemotherapy
Prior cytotoxic chemotherapy ... for any reason
Cannot have received: endocrine therapy
Prior ... endocrine therapy ... for any reason
Cannot have received: biological therapy
Prior ... biological therapy ... for any reason
Cannot have received: radiation therapy
Prior ... radiotherapy for any reason
Lab requirements
Blood counts
Kidney function
Liver function
Cardiac function
No significant cardiac disease: recent MI/ACS/PCI/CABG, NYHA II-IV CHF, high-risk arrhythmias, angina requiring medication, significant valvular disease, ECG evidence of transmural MI
Adequate organ function; Significant cardiac disease [excluded]: history of MI, ACS, PCI, CABG within 6 months; NYHA II-IV CHF; high-risk arrhythmias; angina requiring medication; significant valvular disease; ECG evidence of transmural MI
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07797218 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 there an age limit?
Yes. Patients must be 70 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