Skip to main content
OpenTrials
Completed

NCT Number: NCT04537286

First-line Nab-paclitaxel Plus Cisplatin Plus Camrelizumab in mTNBC Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • At least one measurable lesion according to RECIST 1.1,
  • ECOG performance status ≤ 1
  • Life expectancy of more than 12 weeks
  • Adequate organ and bone marrow function.

Exclusion criteria

  • 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.
  • Patients who need systemic corticosteroids (> 10 mg prednisone/d) or other immunosuppressive drugs within 14 days before enrollment or during the study period.
  • Symptomatic central nervous system (CNS) disease (patients with asymptomatic treated CNS metastases were permitted)
  • Other malignant diseases within the past 5 years (patients with basal cell skin carcinoma and cervical carcinoma in situ were permitted)
  • Uncontrolled infection.

Treatment and study plan

nab-paclitaxel plus cisplatin plus carilizumab (AP+PD-1)

Drug

Nab-paclitaxel 125 mg/m2,ivgtt,d1, 8 Cisplatin 75 mg/m2,ivgtt,d1 Carilizumab 200mg, ivgtt,d1,q3w

Primary outcomes

  1. PFS

    Time frame: 6 weeks

    Progression free survival

  2. Adverse events

    Time frame: 6 weeks

    Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0)

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

A Prospective, Single-arm, Open-Label, Phase II Study of Nab-paclitaxel Plus Cisplatin Plus Camrelizumab as First-line Treatment in Patients With Metastatic Triple-negative Breast Cancer

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Sep 3, 2020
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.