This is a prospective, randomized, multi-cohort, Phase II clinical trial. The study plans to enroll 120 patients with early-stage or locally advanced, HR-positive, HER2-low breast cancer. The primary objective is to evaluate the efficacy and safety of SHR-A1811 with or without endocrine therapy compared to standard chemotherapy as neoadjuvant treatment.
Eligible subjects will be randomized centrally via an Interactive Web Response System (IWRS) using a block randomization method. Participants will be assigned in a 1:1:1 ratio to one of three treatment cohorts:
Cohort A: SHR-A1811 plus endocrine therapy (letrozole ± ovarian function suppression \[OFS\]) Cohort B: SHR-A1811 monotherapy Cohort C: Standard chemotherapy (investigator's choice of A/EC-T or TEC regimen)
Neoadjuvant Treatment:
Subjects in Cohorts A and B will receive 8 cycles of their assigned regimen. Subjects in Cohort C will receive standard chemotherapy as per the chosen protocol.
Treatment will continue until completion of the regimen, occurrence of unacceptable toxicity, withdrawal of consent, or discontinuation at the investigator's discretion.
Assessments:
Tumor imaging for efficacy evaluation will be performed every 2 cycles, with responses assessed according to RECIST v1.1 criteria. Subjects who complete neoadjuvant treatment and are deemed eligible for surgery will undergo surgical intervention within 4 weeks after treatment completion. Pathological response will be assessed from the surgical specimen. Both radiological and pathological evaluations will be based on the assessments conducted at the study site.
Adjuvant Therapy:
Following surgery, all subjects will receive standard adjuvant endocrine therapy as clinically indicated.
Female, aged ≥18 years and ≤70 years;
Histopathologically confirmed invasive breast cancer with no prior systemic anticancer therapy for breast cancer;
Histopathologically confirmed HR-positive (ER ≥1% and/or PR ≥1%) with HER2-low expression (defined as IHC 1+/2+ and FISH negative);
Stage II-III breast cancer (cT2-cT4 or N+, cM0) according to the 8th edition AJCC Breast Cancer Staging Manual;
Breast cancer not confirmed by histopathological examination;
Bilateral breast cancer, inflammatory breast cancer, or occult breast cancer;
Prior receipt of any form of antitumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.);
Concurrent administration of any other form of antitumor therapy;
Parallel
SHR-A1811
DrugIntravenous infusion at 4.8 mg/kg per dose, administered once every 3 weeks (Q3W). Each 3-week (21-day) period constitutes one treatment cycle, totaling 8 cycles. Administration is via intravenous infusion. The initial infusion duration is 90±10 minutes (including the flush phase). If no infusion-related reactions occur after the first administration, subsequent infusions may be shortened to approximately 30 minutes (not less than 20 minutes, including the flush phase).
Letrozole
Drug2.5 mg orally once daily, taken continuously.
TAC/AC-T
DrugRecommended standard dose
tpCR：ypT0-is/ypN0
ORR
EFS
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First Hospital of China Medical University
Lead sponsor
Liaoning Cancer Hospital & Institute
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
