Status:
SUSPENDED
A Study of First-line JS001 and Nab-paclitaxel Versus Palcelbo and Nab-Paclitaxel in Participants With Advanced Recurrent or Metastatic TNBC
Lead Sponsor:
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Conditions:
Triple Negative Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE3
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 the...
Eligibility Criteria
Inclusion
- 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。
Exclusion
- 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.
Key Trial Info
Start Date :
December 21 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2020
Estimated Enrollment :
375 Patients enrolled
Trial Details
Trial ID
NCT03777579
Start Date
December 21 2018
End Date
July 30 2020
Last Update
August 8 2019
Active Locations (1)
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1
The fifth medical center of PLA general hospital
Beijing, China