OncoMatch/Clinical Trials/NCT06927180
SHR-A1811 Plus Pertuzumab in the Neoadjuvant Treatment of HER2 Positive BC
Is NCT06927180 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Targeted therapy
Chemotherapy
Other
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)
Demographics
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.
Frequently asked questions
Is NCT06927180 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.
Is there an age limit?
Yes. Patients must be 70 years or younger.
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