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TerminatedNCT04335006Updated May 6, 2023

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.

A Phase 3 interventional study of Carelizumab and Nab-paclitaxel in Breast Cancer and Triple Negative Breast Cancer, sponsored by Jiangsu HengRui Medicine Co., Ltd.. Terminated at 1 site in China. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-05-06.

Sponsored by Jiangsu HengRui Medicine Co., Ltd. · Phase 3, Interventional, and Treatment

Why this study was terminated
Sponsor R \& D Strategy Adjustment
Phase
Phase 3
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
Female
01

Study 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).

02

Conditions studied

  • Breast Cancer
  • Triple Negative Breast Cancer

Keywords

  • SHR-1210
  • PD-1
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 80 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd. is the lead sponsor of 559 studies on the registry; 85 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    Experimental A

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

    Drug: Carelizumab · Drug: Nab-paclitaxel · Drug: Apatinib

  • Experimental
    Experimental B

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

    Drug: Carelizumab · Drug: Nab-paclitaxel

  • Active comparator
    Comparator C

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

    Drug: Nab-paclitaxel

Interventions

  • DrugCarelizumab

    Participants receive SHR-1210 intravenously (IV)

    Also known as: SHR-1210

  • DrugNab-paclitaxel

    administered intravenously every 4-week cycle

  • DrugApatinib

    administered orally every 4-week cycle

06

What researchers measure

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

    Time frame: Randomisation to the first occurrence of disease progression or death (through the end of study, approximately 42 months)

Secondary outcomes

  1. 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

    Time frame: Up to approximately 42 months

  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

07

Study locations

1 site
  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
    Guangzhou, Guangdong, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04335006
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
Responsible party
Sponsor
First posted
Apr 6, 2020
Start date
Jul 14, 2020
Primary completion
Apr 14, 2023
Completion
Apr 14, 2023
Last update
May 6, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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