OncoMatch/Clinical Trials/NCT07393425
Neoadjuvant Trastuzumab Deruxtecan (SHR-A1811) + Pertuzumab in HER2+ Breast Cancer
Is NCT07393425 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments for her2 + breast cancer.
Treatment: Trastuzumab Deruxtecan · Pertuzumab · Taxane Chemotherapy · Trastuzumab (or biosimilar) · Pyrotinib 320mg — Patients with Stage II-III HER2-positive breast cancer will receive three cycles of treatment with Trastuzumab Deruxtecan (SHR-A1811) + Pertuzumab, followed by imaging assessment. If clinical complete response (cCR) or radiological complete response/near radiological complete response (rCR/near rCR) is achieved, they will continue to receive an additional three cycles of treatment with Trastuzumab Deruxtecan (SHR-A1811) + Pertuzumab, followed by surgery. If cCR/rCR or near rCR is not achieved, the treatment will be switched to the THPy regimen (paclitaxel-based regimen + Trastuzumab + Pyrotinib) for three cycles.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Other
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) overexpression or amplification (IHC 3+ or IHC 2+ with ISH amplification rate ≥2.0)
Histologically confirmed HER2 receptor positivity, following the 2018 ASCO-CAP HER2 positivity judgment guidelines. Confirmed by pathology laboratory with immunohistochemistry (IHC) score of 3+, or 2+ with positive in situ hybridization (ISH) test (ISH amplification rate ≥2.0).
Disease stage
Required: Stage II, III
Excluded: Stage IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: systemic anti-tumor therapy
must not have received any prior systemic anti-tumor therapy for breast cancer
Cannot have received: anti-tumor therapy or radiotherapy for any malignancy
Exception: cured cervical intraepithelial neoplasiabasal cell carcinomasquamous cell carcinoma
Patients who have received prior anti-tumor therapy or radiotherapy for any malignancy, or have concurrent other malignancies, excluding cured cervical intraepithelial neoplasia, basal cell carcinoma, or squamous cell carcinoma
Lab requirements
Blood counts
absolute neutrophil count (anc) > 1.5 × 10^9/l; platelet count (plt) > 75 × 10^9/l; hemoglobin (hb) > 90 g/l
Kidney function
blood urea nitrogen/urea (bun/urea) and creatinine (cr) < 1.5 × uln
Liver function
total bilirubin < 1.5 × uln; alt and ast < 1.5 × uln; alkaline phosphatase < 2.5 × uln
Cardiac function
left ventricular ejection fraction (lvef) ≥ 55%; qtcf < 470 msec
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07393425 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 or amplification 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 qualify