Neoadjuvant treatment for HR Positive/HER2 Low Breast Cancer using SHR-A1811 and Adebrelimab

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II clinical trial evaluates the safety and efficacy of SHR-A1811 alone or in combination with Adebrelimab as neoadjuvant therapy for patients with Stage II-III HR Positive/HER2 Low Breast Cancer. Participants will receive the treatment for six cycles, followed by surgery within four weeks after the therapy. Efficacy will be monitored every two cycles to assess the response to the treatment. The study aims to provide insights into the potential benefits of this combination therapy in improving surgical outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• Shengjing Hospital affiliated to China Medical University
  Shenyang, Liaoning, China Recruiting

Study contacts

• Principal investigator: Caigang Liu, MD — Shengjing Hospital
• Study coordinator: Nan Niu, MD
• Email: niunannancy@163.com
• Phone: 86-18940256668

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.