SHR-A1811 Versus Investigator's Chemotherapy in Recurrent/Metastatic Breast Cancer Clinical Trial
NCT05814354 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 530
Last updated 2023-07-20
Summary
The aim of this study was to evaluate whether the progression-free survival of SHR-A1811 was superior to investigator-selected chemotherapy in patients with HER2-low recurrent/metastatic breast cancer. To evaluate whether SHR-A1811 is superior to investigator-selected chemotherapy in patients with HER2-low recurrent/metastatic breast cancer.
Conditions
Interventions
- DRUG
-
SHR-A1811
SHR-A1811 is a lyophilized powder for injection intravenously. Administered according to label, as one option for Physician's Choice.
- DRUG
-
Capecitabine/Eribulin/Gemcitabine/Paclitaxel/Nab-paclitaxel
Administered according to label, as one option for Physician's Choice (determined before randomization).
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
- 2023-06-30
- Primary Completion
- 2025-01-30
- Completion
- 2026-06-30
Countries
- China
Study Locations
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