OncoMatch/Clinical Trials/NCT06000917
A Study of Neoadjuvant TCHpy（Pyrotinib ，Trastuzumab，Carboplatin and Paclitaxel）for ER+/HER2+ Breast Cancer
Is NCT06000917 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies pyrotinib,Trastuzumab，carboplatin，Albumin paclitaxel for breast cancer.
Treatment: pyrotinib,Trastuzumab，carboplatin，Albumin paclitaxel — This study is a multicenter, single-arm, prospective, open clinical study to evaluate the efficacy and safety of pyrotinib in combination with trastuzumab, albumin paclitaxel, and carboplatin in neoadjuvant therapy for ER+/HER2+ early or locally advanced breast cancer.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) overexpression (HER2-positive)
HER2-positive breast cancer
Required: ESR1 overexpression (ER≥10%)
Hormone receptor status (ER and PgR) is known, where ER≥10%
Disease stage
Required: Stage III
Excluded: Stage IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: antitumor therapy
Exception: excluding cured cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma
Previous antitumor therapy or radiation therapy for any malignancies, excluding cured cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma
Cannot have received: antitumor therapy in other clinical trials (including endocrine therapy, bisphosphonate therapy, or immunotherapy)
Also receiving antitumor therapy in other clinical trials, including endocrine therapy, bisphosphonate therapy, or immunotherapy
Lab requirements
Blood counts
ANC ≥1.5×10^9/L; PLT≥90×10^9/L; Hb ≥90g/L
Kidney function
BUN and Cr≤1.5×ULN and creatinine clearance ≥50 mL/min (Cockcroft-Gault formula)
Liver function
TBIL≤ ULN; ALT and AST≤1.5x ULN; Alkaline phosphatase ≤2.5x ULN
Cardiac function
LVEF≥55% by echocardiography; QTcF <470 ms
Normal function of major organs: blood routine, biochemistry, cardiac color ultrasound and echocardiography: LVEF≥55%; QTcF <470 ms
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06000917 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.
Does this trial require ESR1?
Yes, ESR1 overexpression is a required biomarker for enrollment.
What disease stage is eligible?
Stage III 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 qualify