Suspended
Efficacy and Safety of Sintilimab and Bevacizumab Biosimilar Combined With Pegylated Liposomal Doxorubicin in Pretreated Metastatic Triple-negative Breast Cancer: a Single Arm Phase II Trial
What is being tested
sintilimab
+ bevacizumab biosimilar
+ pegylated liposomal doxorubicin
Drug
Who is being recruted
Breast Diseases+3
+ Breast Neoplasms
+ Neoplasms
From 18 to 70 Years
+19 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 2
Interventional
Study Start: June 2022
Summary
Principal SponsorFudan University
Study ContactBiyun Wang, Prof
Last updated: January 28, 2026Sourced from a government-validated database.Claim as a partner
Study start date: June 15, 2022
Actual date on which the first participant was enrolled.To evaluate the efficacy and safety of sintilimab and bevacizumab biosimilar combined with pegylated liposomal doxorubicin in pretreated metastatic triple-negative breast cancer
Official TitleEfficacy and Safety of Sintilimab and Bevacizumab Biosimilar Combined With Pegylated Liposomal Doxorubicin in Pretreated Metastatic Triple-negative Breast Cancer: a Single Arm Phase II Trial
Principal SponsorFudan University
Study ContactBiyun Wang, Prof
Last updated: January 28, 2026Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
41 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Female
Biological sex of participants that are eligible to enroll.From 18 to 70 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Breast DiseasesBreast NeoplasmsNeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases
Criteria
7 inclusion criteria required to participate
Patients aged 18-70 years old.
Metastatic breast cancer included unresectable locally advanced breast cancer, de novo stage IV breast cancer, and recurrent metastatic breast cancer.
ER and PR negative, HER2 negative breast cancer.
Received one or two lines of systemic treatment in metastatic setting
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12 exclusion criteria prevent from participating
Has received any prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent
Has received any prior therapy with bevacizumab.
Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent)
Has a known additional malignancy that is progressing or has required active treatment within the past 5 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (eg, cervical cancer in situ) that have undergone potentially curative therapy
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Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Experimentalsintilimab 200mg, ivgtt，d1， bevacizumab biosimilar 15mg/kg，ivgtt d1， pegylated liposomal doxorubicin 30mg/m2 d1，q3w
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Recruiting
Fudan University Shanghai Cancer Center
Shanghai, ChinaOpen Fudan University Shanghai Cancer Center in Google MapsSuspendedOne Study Center