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.