Trials / Recruiting
RecruitingNCT05814354
SHR-A1811 Versus Investigator's Chemotherapy in Recurrent/Metastatic Breast Cancer Clinical Trial
A Randomized, Open, Parallel-controlled, Multicenter Phase III Trial of SHR-A1811 Versus Investigator Chemotherapy in HER2-low Expressing Recurrent/Metastatic Breast Cancer
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 530 (estimated)
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd. · Industry
- Sex
- Female
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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). |
Timeline
- Start date
- 2023-06-30
- Primary completion
- 2025-01-30
- Completion
- 2026-06-30
- First posted
- 2023-04-14
- Last updated
- 2023-07-20
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05814354. Inclusion in this directory is not an endorsement.