A Phase II Study of SHR-A1811 Alone or in Combination With Adebrelimab as Neoadjuvant Treatment in HR Positive/HER2 Low Breast Cancer

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
Shengjing Hospital affiliated to China Medical University
RECRUITING
Shenyang
Contact Information
Primary
Nan Niu, MD
niunannancy@163.com
86-18940256668
Time Frame
Start Date: 2024-08-23
Estimated Completion Date: 2031-02-28
Participants
Target number of participants: 93
Treatments
Experimental: Arm 1 (PD-L1 Positive) SHR-A1811 Injection + Adebrelimab Injection
SHR-A1811 Injection + Adebrelimab Injection Drug: SHR-A1811 Injection Drug: Adebrelimab Injection
Experimental: Arm 2 (PD-L1 Negative) SHR-A1811 Injection + Adebrelimab Injection
SHR-A1811 Injection + Adebrelimab Injection Drug: SHR-A1811 Injection Drug: Adebrelimab Injection
Experimental: Arm 3 SHR-A1811 Injection
SHR-A1811 Injection Drug: SHR-A1811 Injection
Related Therapeutic Areas
Sponsors
Leads: Shengjing Hospital
Collaborators: Jiangsu HengRui Medicine Co., Ltd.

This content was sourced from clinicaltrials.gov