Recruiting
A Prospective, Single-arm, Open-Label, Phase II Study of Nab-paclitaxel Plus Cisplatin Plus Carilizumab as First-line Treatment in Patients With Metastatic Triple-negative Breast Cancer
What is being tested
nab-paclitaxel plus cisplatin plus carilizumab (AP+PD-1)
Drug
Who is being recruted
Breast Diseases+3
+ Breast Neoplasms
+ Neoplasms
From 18 to 70 Years
+16 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 2
Interventional
Study Start: August 2020
Summary
Principal SponsorFudan University
Study ContactBiyun Wang, Professor
Last updated: January 28, 2026Sourced from a government-validated database.Claim as a partner
Study start date: August 25, 2020
Actual date on which the first participant was enrolled.To evaluate the efficacy and safety of nab-paclitaxel plus cisplatin plus carilizumab as first-line treatment in patients with metastatic triple-negative breast cancer.
Official TitleA Prospective, Single-arm, Open-Label, Phase II Study of Nab-paclitaxel Plus Cisplatin Plus Carilizumab as First-line Treatment in Patients With Metastatic Triple-negative Breast Cancer
Principal SponsorFudan University
Study ContactBiyun Wang, Professor
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
90 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
8 inclusion criteria required to participate
Female patients aged 18-70 years who had
Metastatic TNBC. ER, PgR, and HER2 status were determined locally by immunohistochemistry (IHC) of patient primary or metastatic tumor sections. Metastatic disease was confirmed by clinical, imaging, histological or cytological measures.
Patients were required to receive no previous chemotherapy or targeted therapy for metastatic triple-negative breast cancer.
Patients who had received adjuvant/neoadjuvant therapy were required an interval for at least 6 months after stop of chemotherapy before the enrollment.
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8 exclusion criteria prevent from participating
Patient of childbearing potential but unwilling to receive contraception.
Radiation therapy of axial bone within 4 weeks before enrollment.
Previous treatment with PD-1 antibody, PD-L1 antibody and CTLA-4 antibody.
Patients have active autoimmune diseases.
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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
ExperimentalNab-paclitaxel 125 mg/m2，ivgtt，d1, 8 Cisplatin 75 mg/m2，ivgtt，d1 Carilizumab 200mg, ivgtt，d1，q2w
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 MapsRecruiting
One Study Center