SHR-A1811 Alone or in Combination With Adebrelimab as Neoadjuvant Treatment in HR Positive/HER2 Low Breast Cancer
- Conditions
- HR Positive/HER2 Low Breast Cancer
- Interventions
- Drug: SHR-A1811 InjectionDrug: SHR-A1811 Injection + Adebrelimab Injection
- Registration Number
- NCT06340230
- Lead Sponsor
- Shengjing Hospital
- Brief Summary
This is an open-label, phase II study evaluating the efficacy and safety of SHR-A1811 alone or in combination with Adebrelimab in Stage II-III HR Positive/HER2 Low Breast Cancer. Subjects will receive the neoadjuvant therapy of SHR-A1811 alone or in combination with Adebrelimab for six cycles, and then undergo surgery within 4 weeks after neoadjuvant therapy. Efficacy will be assessed every 2 cycles.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 93
- Female patients aged ≥ 18 but ≤ 75 years
- Histologically confirmed to be HR+/HER2-Low invasive breast cancer
- Treatment-naive patients with stage II-III
- Eastern Cooperative Oncology Group (ECOG) score is 0 or 1
- Good level of organ function
- Subjects must participate voluntarily, sign the informed consent form, have good compliance, and cooperate with follow-up visits
- Previously been treated with any anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.)
- Received any other anti-tumor therapy at the same time
- Bilateral breast cancer, inflammatory breast cancer or occult breast cancer
- Stage IV breast cancer
- Not confirmed by histopathology
- With a history of any malignancies in the past 5 years, excluding cured cervical carcinoma in situ and melanoma skin cancer
- Participated in other drug clinical trials within 4 weeks before enrollment
- Known allergic history of the drug components of this protocol
- History of immunodeficiency
- Clinically significant cardiovascular diseases
- Known or suspected interstitial lung disease
- Active hepatitis and liver cirrhosis
- Known hereditary or acquired bleeding thrombotic tendency
- History of neurological or psychiatric disorders
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 3 SHR-A1811 Injection SHR-A1811 Injection SHR-A1811 Injection Drug: SHR-A1811 Injection Arm 2 (PD-L1 Negative) SHR-A1811 Injection + Adebrelimab Injection SHR-A1811 Injection + Adebrelimab Injection SHR-A1811 Injection + Adebrelimab Injection Drug: SHR-A1811 Injection Drug: Adebrelimab Injection Arm 1 (PD-L1 Positive) SHR-A1811 Injection + Adebrelimab Injection SHR-A1811 Injection + Adebrelimab Injection SHR-A1811 Injection + Adebrelimab Injection Drug: SHR-A1811 Injection Drug: Adebrelimab Injection
- Primary Outcome Measures
Name Time Method Total pathological complete response (tpCR: ypT0-is/ypN0) At the time of surgery
- Secondary Outcome Measures
Name Time Method Best overall response rate (BORR) During 18 weeks of the neoadjuvant treatment Overall survival (OS) 5 years Event-free survival (EFS) 5 years Health-related quality of life (HRQOL) (EORTC QLQ-C30) During 18 weeks of the neoadjuvant treatment The European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) Core 30 (EORTC QLQ-C30)
Breast pathological complete response (bpCR：ypT0-is) At the time of surgery Health-related quality of life (HRQOL) During 18 weeks of the neoadjuvant treatment The European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire Breast Cancer (EORTC QLQ- BR23) will be used to measure the HRQOL
Residual cancer burden (RCB) At the time of surgery Disease-free survival (DFS) 5 years
Trial Locations
- Locations (1)
Shengjing Hospital affiliated to China Medical University
🇨🇳Shenyang, Liaoning, China