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.

NCT04335006 | Terminated Phase 3 DMC

• 1 other identifier: SHR-1210-III-318
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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).

Conditions

Breast Cancer; Triple Negative Breast Cancer

Keywords

SHR-1210; PD-1

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Progression Free Survival (PFS)

  Up to approximately 42 months

• Overall Survival (OS) in PD-L1 positive/ITT population

  Up to approximately 42 months

• Objective response rate (ORR) in the PD-L1-positive/ITT population

  Up to approximately 42 months

• 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

• Percentage of Participants with Adverse Events (AEs)

  Up to approximately 42 months

Study Arms (3)

Experimental A

EXPERIMENTAL

Subjects receive Carelizumab in combination with Nab-paclitaxel plus Apatinib,each 4-week cycle

Drug: Carelizumab; Drug: Nab-paclitaxel; Drug: Apatinib

Experimental B

EXPERIMENTAL

Subjects receive Carelizumab in combination with Nab-paclitaxel,each 4-week cycle

Drug: Carelizumab; Drug: Nab-paclitaxel

Comparator C

ACTIVE COMPARATOR

Subjects receive nab-paclitaxel intravenously each 4-week cycle.

Drug: Nab-paclitaxel

Interventions

Carelizumab DRUG

Participants receive SHR-1210 intravenously (IV)

Also known as: SHR-1210

Experimental A; Experimental B

Nab-paclitaxel DRUG

administered intravenously every 4-week cycle

Comparator C; Experimental A; Experimental B

Apatinib DRUG

administered orally every 4-week cycle

Experimental A

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Location

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Interventions

camrelizumab; 130-nm albumin-bound paclitaxel; apatinib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2020
• First Posted: April 6, 2020
• Study Start: July 14, 2020
• Primary Completion: April 14, 2023
• Study Completion: April 14, 2023
• Last Updated: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)