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.

  • End date
    Jan 1, 2024
  • participants needed
  • sponsor
    Jiangsu HengRui Medicine Co., Ltd.
Updated on 24 January 2021
measurable disease
breast cancer
advanced breast cancer
solid tumour
triple negative breast cancer
stage iv breast cancer
locally advanced breast cancer
triple-negative breast cancer


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).

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
Treatment Nab-paclitaxel, apatinib, Carelizumab
Clinical Study IdentifierNCT04335006
SponsorJiangsu HengRui Medicine Co., Ltd.
Last Modified on24 January 2021


Yes No Not Sure

Inclusion Criteria

ECOG Performance Status of 0-1
Expected lifetime of not less than three months
Metastatic or locally advanced, histologically documented TNBC (absence of HER2, ER, and PR expression)
Cancer stage: locally advanced or metastatic breast cancer; Locally advanced breast cancer not amenable to radical resection
No prior systemic antitumor therapy for metastatic triple-negative breast cancer
Adequate hematologic and organ function
Measurable disease according to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1)

Exclusion Criteria

Known central nervous system (CNS) disease
Previously received anti-VEGFR small molecule tyrosine kinase inhibitors or anti-PD-1/PD-L1 antibody
A history of bleeding, any serious bleeding events
Uncontrolled pleural effusion, pericardial effusion
Malignancies other than TNBC within 5 years prior to randomisation, or ascites requiring recurrent drainage procedures
History of interstitial pneumonitis
Severe chronic or active infections in need of systemic antibacterial, antifungal, or antiviral treatment, including TB, etc
Prior allogeneic stem cell or solid organ transplantation
History of autoimmune disease
Active hepatitis B or hepatitis C
Pregnancy or lactation
Peripheral neuropathy grade 2
Participants with poor blood pressure control
Myocardial infarction incident within 6 months prior to randomisation
Treatment with systemic immunostimulatory agents within 4 weeks prior to randomisation
Treatment with systemic immunosuppressive medications within 2 weeks prior to randomisation
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