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

CSPC Pharmaceutical Group

Status and phase: Suspended; Phase 3

Conditions: Triple Negative Breast Cancer

Treatments: Drug: JS001，an engineered anti-PD-1 antibody; Drug: Placebo; Drug: Nab-Paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT03777579

NABP201801

Details and patient eligibility

About

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).

Enrollment: 375 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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375 participants in 2 patient groups, including a placebo group

JS001 Plus Nab-Paclitaxel

Experimental group

Description:

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

Treatment:

Drug: Nab-Paclitaxel

Drug: JS001，an engineered anti-PD-1 antibody

Placebo Plus Nab-Paclitaxel

Placebo Comparator group

Description:

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

Treatment:

Drug: Nab-Paclitaxel

Drug: Placebo