OncoMatch/Clinical Trials/NCT06927180
SHR-A1811 Plus Pertuzumab in the Neoadjuvant Treatment of HER2 Positive BC
Is NCT06927180 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for breast cancer early stage breast cancer (stage 1-3).
Treatment: SHR-A1811 · Pertuzumab · Albumin-Paclitaxel · Docetaxel · Carboplatin · Trastuzumab — The goal of this clinical trial is to evaluate the efficacy and safety of SHR-A1811 plus pertuzumab in combination with or without albumin-paclitaxel neoadjuvant therapy for early or locally advanced HER2-positive breast cancer. The main questions it aims to answer are: * Does the pCR of SHR-A1811 plus pertuzumab with or without albumin-paclitaxel improve compared to the current standard of treatment? * Is the safety of SHR-A1811 plus pertuzumab with or without albumin-paclitaxel better compared to the current standard of treatment? Researchers will compare SHR-A1811+pertuzumab or SHR-A1811+pertuzumab+albumin-paclitaxel to TCbHP to see if SHR-A1811 plus pertuzumab with or without albumin-paclitaxel works to treat early or locally advanced HER2-positive breast cancer. Subjects will be randomly assigned 1:1:1 to： * cohort 1：SHR-A1811 combined with pertuzumab for 6 cycles; * cohort 2：SHR-A1811 combined with pertuzumab and albumin-paclitaxel for 6 cycles; * cohort 3：TCbHP (docetaxel, carboplatin, trastuzumab and pertuzumab) for 6 cycles. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, questionnaires, and scans.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) overexpression (IHC 3+ or FISH positive)
HER2 positive expression means that there is at least one case of tumor cell immunohistochemical staining intensity of 3+ or positive confirmed by fluorescence in situ hybridization [FISH]
Disease stage
Excluded: Stage IV
Clinical T2-T4, with any LN, M0. Stage IV (metastatic) breast cancer [excluded].
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy
Has received chemotherapy, endocrine therapy, targeted therapy, reflex therapy, etc. for this disease
Cannot have received: endocrine therapy
Has received chemotherapy, endocrine therapy, targeted therapy, reflex therapy, etc. for this disease
Cannot have received: targeted therapy
Has received chemotherapy, endocrine therapy, targeted therapy, reflex therapy, etc. for this disease
Cannot have received: radiation therapy
Has received chemotherapy, endocrine therapy, targeted therapy, reflex therapy, etc. for this disease
Lab requirements
Blood counts
Absolute value of neutrophil count ≥ 1.5 × 10^9/L; Hemoglobin ≥ 90g/L; Platelet count ≥ 100 × 10^9/L
Kidney function
Creatinine ≤ 1.5 × ULN
Liver function
Total bilirubin ≤ 1.5 ULN; AST/ALT ≤ 2.5 × ULN
Cardiac function
Left ventricular ejection fraction (LVEF) ≥ 50%
Organ and bone marrow function tests within one month before chemotherapy indicate no contraindications to chemotherapy：Absolute value of neutrophil count ≥ 1.5 × 10^9/L; Hemoglobin ≥ 90g/L; Platelet count ≥ 100 × 10^9/L; Total bilirubin≤1.5 ULN; Creatinine≤1.5 × ULN; AST/ALT ≤ 2.5 × ULN. Cardiac ultrasound: Left ventricular ejection fraction (LVEF ≥ 50%).
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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