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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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ClinicalTrials.gov Identifier: NCT04335006
Recruitment Status : Recruiting
First Posted : April 6, 2020
Last Update Posted : July 16, 2020
Sponsor:
Information provided by (Responsible Party):
Jiangsu HengRui Medicine Co., Ltd.

Brief 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).

Condition or disease Intervention/treatment Phase
Breast Cancer Triple Negative Breast Cancer Drug: Carelizumab Drug: Nab-paclitaxel Drug: Apatinib Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 780 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Estimated Study Start Date : July 14, 2020
Estimated Primary Completion Date : January 1, 2024
Estimated Study Completion Date : January 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Paclitaxel

Arm Intervention/treatment
Experimental: Experimental A
Subjects receive Carelizumab in combination with Nab-paclitaxel plus Apatinib,each 4-week cycle
Drug: Carelizumab
Participants receive SHR-1210 intravenously (IV)
Other Name: SHR-1210

Drug: Nab-paclitaxel
administered intravenously every 4-week cycle

Drug: Apatinib
administered orally every 4-week cycle

Experimental: Experimental B
Subjects receive Carelizumab in combination with Nab-paclitaxel,each 4-week cycle
Drug: Carelizumab
Participants receive SHR-1210 intravenously (IV)
Other Name: SHR-1210

Drug: Nab-paclitaxel
administered intravenously every 4-week cycle

Active Comparator: Comparator C
Subjects receive nab-paclitaxel intravenously each 4-week cycle.
Drug: Nab-paclitaxel
administered intravenously every 4-week cycle




Primary Outcome Measures :
  1. Progression-free Survival (PFS) [ Time Frame: Randomisation to the first occurrence of disease progression or death (through the end of study, approximately 42 months) ]
    Progression-free survival (PFS) as determined by the IRC according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) in PD-L1 positive / ITT population


Secondary Outcome Measures :
  1. Progression Free Survival (PFS) [ Time Frame: Up to approximately 42 months ]
    Progression Free Survival (PFS) as determined by the investigator According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (v1.1) in PD-L1 positive/ITT population

  2. Overall Survival (OS) in PD-L1 positive/ITT population [ Time Frame: Up to approximately 42 months ]
  3. Objective response rate (ORR) in the PD-L1-positive/ITT population [ Time Frame: Up to approximately 42 months ]
  4. Clinical benefit rate (CBR), defined as the proportion of patients with a CR or a PR or stable disease as determined by the investigator according to RECIST 1.1 [ Time Frame: Up to approximately 42 months ]
  5. Percentage of Participants with Adverse Events (AEs) [ Time Frame: Up to approximately 42 months ]
  6. Serum concentration of SHR-1210 and plasma concentration of apatinib [ Time Frame: Up to approximately 42 months ]
  7. Proportion of anti-SHR-1210 antibody (ADA) and neutralizing antibody (Nab) formed during the study from baseline [ Time Frame: Up to approximately 42 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04335006


Contacts
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Contact: Xiaoyu Zhu, MD +86 021-61053363 zhuxiaoyu@hrglobe.cn
Contact: Xia Zhang +86 021-61053363 zhang_xia@hrglobe.cn

Locations
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China, Guangdong
Sun Yat-sen Memorial Hospital, Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China
Contact: Erwei Song, PHD         
Sponsors and Collaborators
Jiangsu HengRui Medicine Co., Ltd.
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Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
ClinicalTrials.gov Identifier: NCT04335006    
Other Study ID Numbers: SHR-1210-III-318
First Posted: April 6, 2020    Key Record Dates
Last Update Posted: July 16, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jiangsu HengRui Medicine Co., Ltd.:
SHR-1210
PD-1
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Apatinib
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors