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.
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- STATUS
- Recruiting
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- End date
- Jan 1, 2024
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- participants needed
- 780
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- sponsor
- Jiangsu HengRui Medicine Co., Ltd.
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).
Details
| Condition | Breast Cancer, Breast Cancer, Diet and Nutrition, Chronic Diarrhea, Skin Wounds, Chronic Shoulder Pain, Vaginal Atrophy, Adverse Effects, Drugs, Injection Port, Breast Cancer - HER2 Positive, Anal Dysplasia, Primary Immunodeficiency, Pediatric Health, Near-Sighted Corrective Surgery, Peripheral Arterial Occlusive Disease, Triple Negative Breast Cancer, Breast Cancer Diagnosis, Brain Function, Recurrent Respiratory Papillomatosis, Razor Bumps (Pseudofolliculitis Barbae), Metastatic Triple-Negative Breast Cancer, breast carcinoma, cancer, breast |
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| Treatment | Nab-paclitaxel, apatinib, Carelizumab |
| Clinical Study Identifier | NCT04335006 |
| Sponsor | Jiangsu HengRui Medicine Co., Ltd. |
| Last Modified on | 24 January 2021 |
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