Trials / Terminated
TerminatedNCT04335006
A Phase 3 Study Comparing Carelizumab Plus Nab-paclitaxel and Apatinib, Carelizumab Plus Nab-paclitaxel, and Nab-paclitaxel in Patients With Advanced Triple Negative Breast Cancer.
A Multicentre, Open-parallel, Randomized, Controlled Phase Ⅲ Study Comparing Carelizumab Plus Nab-paclitaxel and Apatinib, Carelizumab Plus Nab-paclitaxel, and Nab-paclitaxel in Patients With Unresectable Locally Advanced or Metastatic Triple Negative Breast Cancer.
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 80 (actual)
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd. · Industry
- Sex
- Female
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
This randomized, open-label phase 3 study will evaluate the safety and efficacy of Carelizumab (an engineered anti-programmed death-ligand 1 \[PD-1\] antibody) in combination with Nab-paclitaxel and Apatinib, carelizumab plus nab-paclitaxel, and Nab-paclitaxel in Patients with Unresectable Locally Advanced or Metastatic Triple Negative Breast Cancer. Participants will be randomized in a 1:1:1 ratio to Arm A (Carelizumab + Nab-paclitaxel + Apatinib), Arm B (Carelizumab + Nab-paclitaxel), or Arm C (Nab-paclitaxel).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Carelizumab | Participants receive SHR-1210 intravenously (IV) |
| DRUG | Nab-paclitaxel | administered intravenously every 4-week cycle |
| DRUG | Apatinib | administered orally every 4-week cycle |
Timeline
- Start date
- 2020-07-14
- Primary completion
- 2023-04-14
- Completion
- 2023-04-14
- First posted
- 2020-04-06
- Last updated
- 2023-05-06
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04335006. Inclusion in this directory is not an endorsement.