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 (May 2026). This Phase 2 trial studies pyrotinib,Trastuzumab，carboplatin，Albumin paclitaxel for breast cancer.

Phase 2RecruitingUnion Hospital, Tongji Medical College, Huazhong University of Science and TechnologyNCT06000917Data as of May 2026

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.

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Extracted eligibility criteria

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)

Prior therapy

No prior treatment (treatment-naive required)

Max 0 prior lines

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.

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