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Toripalimab in Combination With Nab-Paclitaxel For Patients With Metastatic or Recurrent Triple-Negative Breast Cancer (TNBC) With or Without Systemic Treatment

NCT04085276 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 531

Last updated 2026-04-16

No results posted yet for this study

Summary

This multicenter, randomized, double-blind study will evaluate the efficacy and safety of Toripalimab (JS001) combined with nab-paclitaxel compared with placebo combined with nab-paclitaxel for first/second line treatment of metastatic or recurrent triple-negative breast cancer (TNBC).

Conditions

  • Triple-Negative Breast Cancer

Interventions

DRUG

JS001

JS001 240mg, i.v., q3w; Other name: Toripalimab

DRUG

Nab-Paclitaxel

Nab-Paclitaxel 125 mg/m2, i.v., d1, d8, q3w

DRUG

Placebo

Placebo, i.v., q3w;

DRUG

Nab-Paclitaxel

Nab-Paclitaxel 125 mg/m2, i.v., d1, d8, q3w

Sponsors & Collaborators

  • Shanghai Junshi Bioscience Co., Ltd.

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-21
Primary Completion
2024-12-31
Completion
2025-02-28

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT04085276 on ClinicalTrials.gov