Neoadjuvant SHR-A1811 Plus Adebrelimab in HR Negative/Low & HER2 Low Breast Cancer Patients (NCT06592625) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Neoadjuvant SHR-A1811 Plus Adebrelimab in HR Negative/Low & HER2 Low Breast Cancer Patients
China60 participantsStarted 2024-09-20
Plain-language summary
The study is being conducted to evaluate the preliminary efficacy, safety, and pharmacokinetic characteristics of the combination of SHR-A1811 with Adebrelimab Injection in treatment-naive patients with early-stage or locally advanced HR-negative or low expression, HER2 low expression breast cancer.
Who can participate
Age range18 Years – 75 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Female treatment-naïve patients aged ≥18 years and ≤75 years.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
✓. Breast cancer meeting the following criteria:
✓. Histologically confirmed invasive breast cancer with at least one tumor lesion \>2 cm in diameter.
✓. Clinical stage II or III.
✓. Histologically or cytologically confirmed HR-negative or low expression and HER2 low expression breast cancer.
✓. Adequate major organ function.
✓. Females of childbearing potential must agree to use highly effective contraception methods and avoid egg donation, and must have a negative serum pregnancy test within 7 days prior to the first treatment and during the study period. They must not be breastfeeding.
Exclusion criteria
✕. Tumor-related medical history and treatment history:
✕. Bilateral breast cancer (including contralateral carcinoma in situ).
✕. Stage IV (metastatic) breast cancer.
✕. Inflammatory breast cancer.
✕. Diagnosis of ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) within 5 years.
What they're measuring
1
Investigator-assessed tpCR
Timeframe: Approximately 18 weeks after the first dose (after breast cancer surgery
✕. History of invasive breast cancer or metastatic breast cancer.
✕. Prior surgical resection of the breast primary lesion or axillary lymph nodes before signing the informed consent.
✕. Diagnosis of any malignancy within 5 years before signing the informed consent, excluding adequately treated cervical carcinoma in situ, cutaneous basal cell carcinoma or squamous cellcancer.