A Phase Ib/II Study of SHR-A1811 Injection in Breast Cancer
NCT05353361 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 402
Last updated 2023-09-15
Summary
To evaluate the safety, tolerability and efficacy of SHR-A1811 in combination with pyrotinib or pertuzumab or adebrelimab or albumin-bound paclitaxel in patients with breast cancer.
Conditions
Interventions
- DRUG
-
SHR-A1811:Pyrotinib
SHR-A1811:Lyophilized powder injection, 100mg / bottle, intravenous drip Pyrotinib:Tablet, 160mg / tablet, 80mg / tablet, oral
- DRUG
-
SHR-A1811;Pertuzumab
SHR-A1811:Lyophilized powder injection, 100mg / bottle, intravenous drip Pertuzumab:Injection, 420 Mg (14 ml) / bottle, intravenous drip
- DRUG
-
SHR-A1811;Adebrelimab
SHR-A1811:Lyophilized powder injection, 100mg / bottle, intravenous drip Adebrelimab:Injection, 12ml: 0.6g/bottle, intravenous drip
- DRUG
-
SHR-A1811;Albumin paclitaxel
SHR-A1811:Lyophilized powder injection, 100mg / bottle, intravenous drip Albumin paclitaxel:Injection, 100mg / box, intravenous drip
Sponsors & Collaborators
-
Jiangsu HengRui Medicine Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-05-23
- Primary Completion
- 2025-12-31
- Completion
- 2025-12-31
Countries
- China
Study Locations
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