A Study of First-line JS001 and Nab-paclitaxel Versus Palcelbo and Nab-Paclitaxel in Participants With Advanced Recurrent or Metastatic TNBC
- Conditions
- Triple Negative Breast Cancer
- Interventions
- Registration Number
- NCT03777579
- Lead Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- Female
- Target Recruitment
- 375
- 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。
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description JS001 Plus Nab-Paclitaxel Nab-Paclitaxel Participants assigned to JS001 plus nab-paclitaxel will receive both agents until disease progression or unacceptable toxicity. Placebo Plus Nab-Paclitaxel Placebo Participants assigned to placebo plus nab-paclitaxel will receive both agents until disease progression or unacceptable toxicity. Placebo Plus Nab-Paclitaxel Nab-Paclitaxel Participants assigned to placebo plus nab-paclitaxel will receive both agents until disease progression or unacceptable toxicity. JS001 Plus Nab-Paclitaxel JS001，an engineered anti-PD-1 antibody Participants assigned to JS001 plus nab-paclitaxel will receive both agents until disease progression or unacceptable toxicity.
- Primary Outcome Measures
Name Time Method Progression-Free Survival (PFS) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by Independent Review Committee (IRC) From Day 1 to disease progression (PD) or death from any cause, assessed up to end of study (up to approximately 30 months) 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.
- Secondary Outcome Measures
Name Time Method 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) DCR is defined as the rate of of CR, PR, or stable disease according to RECIST v1.1.
OS rate at 24 months the percent of participants that are alive at 24 months from Day 1. OS is defined as the time from randomization to death from any cause.
PFS Assessed Using immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) by investigator From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months) Progression is confirmed in the target lesion category if the next imaging assessment after iUPD (4-8 weeks later) confirms a further increase in sum of measures of target disease from iUPD, with an increase of at least 5mm.
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) 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.
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) ORR is defined as the rate of CR or PR, as determined by IRC using RECIST v1.1 criteria.
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) DoR is defined as the time period from the date of initial CR or PR until the date of PD or death from any cause, whichever occurs first.
Overall Survival (OS) From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months) OS is defined as the time from randomization to death from any cause.
OS rate at 12 months the percent of participants that are alive at 12months from Day 1. OS is defined as the time from randomization to death from any cause.
Percentage and severity of Participants With Adverse Events (AEs) From Day 1 to 60 days after last dose of study drug, assessed up to end of study (up to approximately 30 months) percentage and CTC AE(v5.0) of AEs
ORR Assessed Using immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) by investigator From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months) ORR is defined as the rate of iCR or iPR, as determined by investigator using iRECIST criteria.
Percentage of Participants With Anti-Drug Antibodies (ATAs) 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) DoR Assessed Using immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) by investigator From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months) DoR is defined as the time period from the date of initial iCR or iPR until the date of iCPD or death from any cause, whichever occurs first.
DCR Assessed Using immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) by investigator From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months) DCR is defined as the rate of of iCR, iPR, or stable disease according to iRECIST.
Trial Locations
- Locations (1)
The fifth medical center of PLA general hospital
🇨🇳Beijing, China