Overview

A Study of First-line JS001 and Nab-paclitaxel Versus Palcelbo and Nab-Paclitaxel in Participants With Advanced Recurrent or Metastatic TNBC

Status:
Suspended
Trial end date:
2020-07-30
Target enrollment:
0
Participant gender:
Female
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).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Collaborator:
TopAlliance Biosciences, Inc.
Treatments:
Albumin-Bound Paclitaxel
Antibodies
Immunoglobulins
Paclitaxel
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.