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.

Breast Cancer Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04335006
• Other study ID #: SHR-1210-III-318
• Status: Terminated
• Phase: Phase 3
• Start date: July 14, 2020
• Est. completion date: April 14, 2023

Study information

• Verified date: May 2023
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 80
• Est. completion date: April 14, 2023
• Est. primary completion date: April 14, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

Intervention

Drug:
• Carelizumab
Participants receive SHR-1210 intravenously (IV)
• Nab-paclitaxel
administered intravenously every 4-week cycle
• Apatinib
administered orally every 4-week cycle

Locations

Country	Name	City	State
China	Sun Yat-sen Memorial Hospital, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free Survival (PFS)	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	Randomisation to the first occurrence of disease progression or death (through the end of study, approximately 42 months)
Secondary	Progression Free Survival (PFS)	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	Up to approximately 42 months
Secondary	Overall Survival (OS) in PD-L1 positive/ITT population		Up to approximately 42 months
Secondary	Objective response rate (ORR) in the PD-L1-positive/ITT population		Up to approximately 42 months
Secondary	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		Up to approximately 42 months
Secondary	Percentage of Participants with Adverse Events (AEs)		Up to approximately 42 months
Secondary	Serum concentration of SHR-1210 and plasma concentration of apatinib		Up to approximately 42 months
Secondary	Proportion of anti-SHR-1210 antibody (ADA) and neutralizing antibody (Nab) formed during the study from baseline		Up to approximately 42 months