SHR-A1811 Alone or in Combination With Adebrelimab as Neoadjuvant Treatment in HR Positive/HER2 Low Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SHR-A1811 Injection + Adebrelimab Injection, SHR-A1811 Injection + Adebrelimab Injection, SHR-A1811 Injection.
- Who it may be relevant to
- Registry conditions: HR Positive/HER2 Low Breast Cancer. Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase II Study of SHR-A1811 Alone or in Combination With Adebrelimab as Neoadjuvant Treatment in HR Positive/HER2 Low Breast Cancer
Overview
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
- Drug SHR-A1811 Injection + Adebrelimab Injection
Drug: SHR-A1811 Injection Drug: Adebrelimab Injection - Drug SHR-A1811 Injection + Adebrelimab Injection
Drug: SHR-A1811 Injection Drug: Adebrelimab Injection - Drug SHR-A1811 Injection
Drug: SHR-A1811 Injection
Primary outcome measures
- Total pathological complete response (tpCR: ypT0-is/ypN0) [Time frame: At the time of surgery]
Secondary outcome measures (8)
- Breast pathological complete response (bpCR：ypT0-is) [Time frame: At the time of surgery]
- Residual cancer burden (RCB) [Time frame: At the time of surgery]
- Best overall response rate (BORR) [Time frame: During 18 weeks of the neoadjuvant treatment]
- Overall survival (OS) [Time frame: 5 years]
- Disease-free survival (DFS) [Time frame: 5 years]
- Event-free survival (EFS) [Time frame: 5 years]
- Health-related quality of life (HRQOL) (EORTC QLQ-C30) [Time frame: During 18 weeks of the neoadjuvant treatment]
- Health-related quality of life (HRQOL) [Time frame: During 18 weeks of the neoadjuvant treatment]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shengjing Hospital affiliated to China Medical University — Shenyang
Identifiers
NCT: NCT06340230 · BC-NEO-IIT-SHR-A1811-SHR1316