Clinical trial NCT03777579: A Study of First-line JS001 and Nab-paclitaxel Versus Palcelbo and Nab-Paclitaxel in Participants With Advanced Recurrent or Metastatic TNBC
Official title: A Phase III, Multicenter, Randomized, Placebo-Controlled Study of JS001 (Anti-PD-1 Antibody) in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel as First-line Therapy for Patients With Primarily Diagnose or Recurrent and Metastatic Triple-Negative Breast Cancer
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE3
Conditions: Triple Negative Breast Cancer
Lead sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-12-17
Enrollment: 375
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

1. 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;
2. No prior chemotherapy or targeted systemic therapy for inoperable stage IV or metastatic TNBC；
3. Eligible for taxane monotherapy；
4. Eastern Cooperative Oncology Group performance status of 0 or 1；
5. Measurable disease as defined by RECIST v1.1；
6. Adequate hematologic and end-organ function。

Exclusion Criteria:

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

Primary outcomes:
measure: Progression-Free Survival (PFS) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by Independent Review Committee (IRC)
timeFrame: 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:
measure: Progression-Free Survival (PFS) Assessed Using RECIST v1.1 by investigator
timeFrame: From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months)
measure: Objective response rate (ORR) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by IRC
timeFrame: From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months)
measure: Duration of response (DoR) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by IRC
timeFrame: From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months)
measure: Disease control rate (DCR) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by IRC
timeFrame: From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months)
measure: Overall Survival (OS)
timeFrame: From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)
measure: OS rate at 12 months
timeFrame: the percent of participants that are alive at 12months from Day 1.
measure: OS rate at 24 months
timeFrame: the percent of participants that are alive at 24 months from Day 1.
measure: PFS Assessed Using immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) by investigator
timeFrame: From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)
measure: ORR Assessed Using immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) by investigator
timeFrame: From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)
measure: DoR Assessed Using immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) by investigator
timeFrame: From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)
measure: DCR Assessed Using immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) by investigator
timeFrame: From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)
measure: Percentage and severity of Participants With Adverse Events (AEs)
timeFrame: From Day 1 to 60 days after last dose of study drug, assessed up to end of study (up to approximately 30 months)
measure: Percentage of Participants With Anti-Drug Antibodies (ATAs)
timeFrame: Pre-dose (60minutes±10minutes) on Day 1 of Cycles 1, 3, 5, 7, 9 and at every 6 cycles thereafter until disease progression, at disease progression. (maximum up to 30 months) (1 Cycle = 21 days)
Other outcomes:
Locations:
city: Beijing
country: China
facility: The fifth medical center of PLA general hospital
Study officials:
affiliation: Beijing 302 Hospital
name: JIANG ZE FEI, PHD
role: PRINCIPAL_INVESTIGATOR
References: