SHR-A1811 Alone or in Combination With Adebrelimab as Neoadjuvant Treatment in HR Positive/HER2 Low Breast Cancer
A Phase II Study of SHR-A1811 Alone or in Combination With Adebrelimab as Neoadjuvant Treatment in HR Positive/HER2 Low Breast Cancer
Shengjing Hospital
93 participants
Aug 23, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- 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 Criteria14
- 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
Interventions
Drug: SHR-A1811 Injection Drug: Adebrelimab Injection
Drug: SHR-A1811 Injection Drug: Adebrelimab Injection
Drug: SHR-A1811 Injection
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06340230