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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorShengjing Hospital

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • SHR-A1811 Injection + Adebrelimab Injection
  • SHR-A1811 Injection + Adebrelimab Injection
  • SHR-A1811 Injection

Treatment groups

93 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Shengjing Hospital

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Collaborator