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

NCT ID: NCT03777579

Last Updated: 2019-08-08

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE3
• Total Enrollment: 375 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-21
• Study Completion Date: 2020-07-30

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).

Conditions

Triple Negative Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

JS001 Plus Nab-Paclitaxel

Participants assigned to JS001 plus nab-paclitaxel will receive both agents until disease progression or unacceptable toxicity.

Group Type: EXPERIMENTAL

JS001，an engineered anti-PD-1 antibody

Intervention Type: DRUG

JS001 at a fixed dose of 240 milligrams via intravenous (IV) infusion on Days 1 of each 21-day cycle until disease progression or unacceptable toxicity.

Nab-Paclitaxel

Intervention Type: DRUG

Nab-Paclitaxel at a starting dose of 125mg per square meter via IV infusion on Days 1, 8 of each 21-day cycle. Nab-Paclitaxel will be administered until disease progression or unacceptable toxicity.

Placebo Plus Nab-Paclitaxel

Participants assigned to placebo plus nab-paclitaxel will receive both agents until disease progression or unacceptable toxicity.

Group Type: PLACEBO_COMPARATOR

Nab-Paclitaxel

Intervention Type: DRUG

Nab-Paclitaxel at a starting dose of 125mg per square meter via IV infusion on Days 1, 8 of each 21-day cycle. Nab-Paclitaxel will be administered until disease progression or unacceptable toxicity.

Placebo

Intervention Type: DRUG

Placebo administered via intravenous (IV) infusion on Days 1 of each 21-day cycle until disease progression or unacceptable toxicity.

Interventions

JS001，an engineered anti-PD-1 antibody

JS001 at a fixed dose of 240 milligrams via intravenous (IV) infusion on Days 1 of each 21-day cycle until disease progression or unacceptable toxicity.

Intervention Type: DRUG

Nab-Paclitaxel

Nab-Paclitaxel at a starting dose of 125mg per square meter via IV infusion on Days 1, 8 of each 21-day cycle. Nab-Paclitaxel will be administered until disease progression or unacceptable toxicity.

Intervention Type: DRUG

Placebo

Placebo administered via intravenous (IV) infusion on Days 1 of each 21-day cycle until disease progression or unacceptable toxicity.

Intervention Type: DRUG

Other Intervention Names

Terepril monoclonal antibody; Paclitaxel For Injection（Albumin Bound）

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

JIANG ZE FEI, PHD

Role: PRINCIPAL_INVESTIGATOR

Beijing 302 Hospital

Locations

The fifth medical center of PLA general hospital

Beijing, , China

Countries

China

References

Jiang Z, Ouyang Q, Sun T, Zhang Q, Teng Y, Cui J, Wang H, Yin Y, Wang X, Zhou X, Wang Y, Sun G, Wang J, Zhang L, Yang J, Qian J, Yan M, Liu X, Yi T, Cheng Y, Li M, Zang A, Wang S, Wang C, Wu X, Cheng J, Li H, Lin Y, Geng C, Gu K, Xie C, Xiong H, Wu X, Yang J, Li Q, Chen Y, Li F, Zhang A, Zhang Y, Wu Y, Nie J, Liu Q, Wang K, Mo X, Chen L, Pan Y, Fu P, Zhang H, Pang D, Sheng Y, Han Y, Wang H, Cang S, Luo X, Yu W, Deng R, Yang C, Keegan P. Toripalimab plus nab-paclitaxel in metastatic or recurrent triple-negative breast cancer: a randomized phase 3 trial. Nat Med. 2024 Jan;30(1):249-256. doi: 10.1038/s41591-023-02677-x. Epub 2024 Jan 8.

Reference Type: DERIVED

PMID: 38191615 (View on PubMed)

Other Identifiers

NABP201801

Identifier Type: -

Identifier Source: org_study_id