SHR-A1811 Alone or in Combination With Adebrelimab as Neoadjuvant Treatment in HR Positive/HER2 Low Breast Cancer

Recruiting now · Phase 2

Conditions studied: HR Positive/HER2 Low Breast Cancer

In brief

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.

Key facts

Study ID

NCT06340230

Run by

Shengjing Hospital

People needed

93

Starts

2024-08-23

Expected to finish

2031-02-28

Last updated by the study team

2024-12-04

Who can join

Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Shengjing Hospital affiliated to China Medical University — Shenyang, Liaoning, China (enrolling)

Full record on ClinicalTrials.gov

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