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A Study of Camrelizumab in Combination With Chemotherapy Regimen Comparative Chemotherapy Regimen for Metastatic Triple-negative Breast Cancer

NCT05134194 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2024-04-16

No results posted yet for this study

Summary

Approximately 104 subjects with recurrent or metastatic IM triple negative breast cancer were planned to be included in the study, and screened eligible subjects were randomly assigned in a 1:1 ratio to treatment with the combination of Camrelizumab and investigator's choice of chemotherapy (test arm), treatment with investigator's choice of chemotherapy (control arm), and the stratification factor was liver metastasis (with vs without). After enrollment, subjects in the test group were treated with Camrelizumab 200 mg IV every 3 weeks for one cycle. The investigator's choice of single agent chemotherapy regimen (capecitabine, eribulin, gemcitabine, or vinorelbine) was every 3 weeks for one cycle until disease progression, intolerable toxicity, withdrawal of informed consent, or discontinuation at the investigator's discretion.

Conditions

Interventions

DRUG

Camrelizumab、Capecitabine/eribulin/gemcitabine/vinorelbine

Camrelizumab in combination with capecitabine or eribulin or gemcitabine or vinorelbine

DRUG

Capecitabine/eribulin/gemcitabine/vinorelbine

Capecitabine or eribulin or gemcitabine or vinorelbine

Sponsors & Collaborators

  • Suzhou Suncadia Biopharmaceuticals Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-17
Primary Completion
2022-01-17
Completion
2022-12-15

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05134194 on ClinicalTrials.gov