Clinical Study of SHR-A1811 With or Without Letrozole in Neoadjuvant Therapy for Early-Stage HR-P… (NCT07305246) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Clinical Study of SHR-A1811 With or Without Letrozole in Neoadjuvant Therapy for Early-Stage HR-Positive, HER2-Low Breast Cancer
120 participantsStarted 2025-12
Plain-language summary
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.
Who can participate
Age range18 Years – 70 Years
SexFEMALE
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Inclusion criteria
✓. 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;
✓. At least one measurable target lesion per RECIST V1.1;
✓. ECOG performance status score of 0 to 1;
✓. Organ function levels must meet the following requirements (no corrective therapy with blood components or growth factors within 14 days prior to first dose):
✕. 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;
✕. History of other malignancies within the past 5 years, except for cured basal cell carcinoma of the skin and cervical carcinoma in situ;
✕. Participation in other drug clinical trials within 4 weeks prior to randomization;
✕. Administration of live or attenuated vaccines within 4 weeks prior to randomization;
✕. Undergone major non-breast cancer-related surgical procedures within 4 weeks prior to randomization, or not yet fully recovered from such procedures;