NCT03777579

Brief Summary

This multicenter, randomized, double-blind study will evaluate the efficacy, safety of JS001 administered with nab-paclitaxel compared with placebo in combination with nab-paclitaxel as first-line therapy in participants with primarily diagnosed stage IV and recurrent or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic breast cancer (mBC).

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
375

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 17, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

December 21, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2020

Completed
Last Updated

August 8, 2019

Status Verified

December 1, 2018

Enrollment Period

1 year

First QC Date

December 12, 2018

Last Update Submit

August 6, 2019

Conditions

Triple Negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Progression-Free Survival (PFS) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by Independent Review Committee (IRC)

    PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator using RECIST v1.1, or death from any cause during the study, whichever occurs first. PD is defined as greater than or equal to (\>/=) 20 percent (%) relative increase and \>/=5 millimeter (mm) of absolute increase in the sum of diameters (SD) of target lesions (TLs), taking as reference the smallest SD recorded since treatment started, or appearance of 1 or more new lesions.

    From Day 1 to disease progression (PD) or death from any cause, assessed up to end of study (up to approximately 30 months)

Secondary Outcomes (13)

  • Progression-Free Survival (PFS) Assessed Using RECIST v1.1 by investigator

    From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months)

  • Objective response rate (ORR) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by IRC

    From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months)

  • Duration of response (DoR) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by IRC

    From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months)

  • Disease control rate (DCR) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by IRC

    From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months)

  • Overall Survival (OS)

    From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)

  • +8 more secondary outcomes

Study Arms (2)

JS001 Plus Nab-Paclitaxel

EXPERIMENTAL

Participants assigned to JS001 plus nab-paclitaxel will receive both agents until disease progression or unacceptable toxicity.

Drug: JS001，an engineered anti-PD-1 antibodyDrug: Nab-Paclitaxel

Placebo Plus Nab-Paclitaxel

PLACEBO COMPARATOR

Participants assigned to placebo plus nab-paclitaxel will receive both agents until disease progression or unacceptable toxicity.

Drug: Nab-PaclitaxelDrug: Placebo

Interventions

JS001，an engineered anti-PD-1 antibodyDRUG

JS001 at a fixed dose of 240 milligrams via intravenous (IV) infusion on Days 1 of each 21-day cycle until disease progression or unacceptable toxicity.

Also known as: Terepril monoclonal antibody
JS001 Plus Nab-Paclitaxel
Nab-PaclitaxelDRUG

Nab-Paclitaxel at a starting dose of 125mg per square meter via IV infusion on Days 1, 8 of each 21-day cycle. Nab-Paclitaxel will be administered until disease progression or unacceptable toxicity.

Also known as: Paclitaxel For Injection（Albumin Bound）
JS001 Plus Nab-PaclitaxelPlacebo Plus Nab-Paclitaxel
PlaceboDRUG

Placebo administered via intravenous (IV) infusion on Days 1 of each 21-day cycle until disease progression or unacceptable toxicity.

Placebo Plus Nab-Paclitaxel

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primarily diagnosed stage IV or recurrent and metastatic, histologically documented TNBC characterized by absence of human epidermal growth factor 2 (HER2), estrogen receptor (ER), and progesterone receptor (PR) expression;
  • No prior chemotherapy or targeted systemic therapy for inoperable stage IV or metastatic TNBC；
  • Eligible for taxane monotherapy；
  • Eastern Cooperative Oncology Group performance status of 0 or 1；
  • Measurable disease as defined by RECIST v1.1；
  • Adequate hematologic and end-organ function。

You may not qualify if:

  • Known central nervous system (CNS) disease with active syndrome or untreated disease, except for treated asymptomatic CNS metastases；
  • History of autoimmune disease；
  • History of Anaphylaxis to PD-(L)1 antibody or CTLA-4 antibody or paclitaxel;
  • Prior allogeneic stem cell or solid organ transplantation;
  • Active hepatitis B or hepatitis C;
  • Positive of HIV antibody.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The fifth medical center of PLA general hospital

Beijing, China

Location

Related Publications (1)

  • Jiang Z, Ouyang Q, Sun T, Zhang Q, Teng Y, Cui J, Wang H, Yin Y, Wang X, Zhou X, Wang Y, Sun G, Wang J, Zhang L, Yang J, Qian J, Yan M, Liu X, Yi T, Cheng Y, Li M, Zang A, Wang S, Wang C, Wu X, Cheng J, Li H, Lin Y, Geng C, Gu K, Xie C, Xiong H, Wu X, Yang J, Li Q, Chen Y, Li F, Zhang A, Zhang Y, Wu Y, Nie J, Liu Q, Wang K, Mo X, Chen L, Pan Y, Fu P, Zhang H, Pang D, Sheng Y, Han Y, Wang H, Cang S, Luo X, Yu W, Deng R, Yang C, Keegan P. Toripalimab plus nab-paclitaxel in metastatic or recurrent triple-negative breast cancer: a randomized phase 3 trial. Nat Med. 2024 Jan;30(1):249-256. doi: 10.1038/s41591-023-02677-x. Epub 2024 Jan 8.

    PMID: 38191615DERIVED

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

130-nm albumin-bound paclitaxelPaclitaxel

Condition Hierarchy (Ancestors)

Breast NeoplasmsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • JIANG ZE FEI, PHD

    Beijing 302 Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2018

First Posted

December 17, 2018

Study Start

December 21, 2018

Primary Completion

December 30, 2019

Study Completion

July 30, 2020

Last Updated

August 8, 2019

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)