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.
NCT ID: NCT04335006
Last Updated: 2023-05-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
80 participants
INTERVENTIONAL
2020-07-14
2023-04-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental A
Subjects receive Carelizumab in combination with Nab-paclitaxel plus Apatinib,each 4-week cycle
Carelizumab
Participants receive SHR-1210 intravenously (IV)
Nab-paclitaxel
administered intravenously every 4-week cycle
Apatinib
administered orally every 4-week cycle
Experimental B
Subjects receive Carelizumab in combination with Nab-paclitaxel,each 4-week cycle
Carelizumab
Participants receive SHR-1210 intravenously (IV)
Nab-paclitaxel
administered intravenously every 4-week cycle
Comparator C
Subjects receive nab-paclitaxel intravenously each 4-week cycle.
Nab-paclitaxel
administered intravenously every 4-week cycle
Interventions
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Carelizumab
Participants receive SHR-1210 intravenously (IV)
Nab-paclitaxel
administered intravenously every 4-week cycle
Apatinib
administered orally every 4-week cycle
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
70 Years
FEMALE
No
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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Other Identifiers
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SHR-1210-III-318
Identifier Type: -
Identifier Source: org_study_id
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