HR Positive/HER2 Low Breast Cancer
Conditions
Keywords
SHR-A1811, Adebrelimab, Neoadjuvant, HR Positive/HER2 Low Breast Cancer
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.
Interventions
DRUGSHR-A1811 Injection + Adebrelimab Injection
Drug: SHR-A1811 Injection Drug: Adebrelimab Injection
Drug: SHR-A1811 Injection
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Shengjing Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Female patients aged ≥ 18 but ≤ 75 years 2. Histologically confirmed to be HR+/HER2-Low invasive breast cancer 3. Treatment-naive patients with stage II-III 4. Eastern Cooperative Oncology Group (ECOG) score is 0 or 1 5. Good level of organ function 6. Subjects must participate voluntarily, sign the informed consent form, have good compliance, and cooperate with follow-up visits
Exclusion criteria
1. Previously been treated with any anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.) 2. Received any other anti-tumor therapy at the same time 3. Bilateral breast cancer, inflammatory breast cancer or occult breast cancer 4. Stage IV breast cancer 5. Not confirmed by histopathology 6. With a history of any malignancies in the past 5 years, excluding cured cervical carcinoma in situ and melanoma skin cancer 7. Participated in other drug clinical trials within 4 weeks before enrollment 8. Known allergic history of the drug components of this protocol 9. History of immunodeficiency 10. Clinically significant cardiovascular diseases 11. Known or suspected interstitial lung disease 12. Active hepatitis and liver cirrhosis 13. Known hereditary or acquired bleeding thrombotic tendency 14. History of neurological or psychiatric disorders
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total pathological complete response (tpCR: ypT0-is/ypN0) | At the time of surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | 5 years | — |
| Disease-free survival (DFS) | 5 years | — |
| Event-free survival (EFS) | 5 years | — |
| Breast pathological complete response (bpCR：ypT0-is) | At the time of surgery | — |
| Residual cancer burden (RCB) | At the time of surgery | — |
| Best overall response rate (BORR) | During 18 weeks of the neoadjuvant treatment | — |
| 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) |
| 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 |
Countries
China
Contacts
Primary ContactNan Niu, MD
Outcome results
None listed