## Protocol Section
### Identification Module
**NCT ID:** NCT03777579

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

**Official Title:** A Phase III, Multicenter, Randomized, Placebo-Controlled Study of JS001 (Anti-PD-1 Antibody) in Combination With Nab-Paclitaxel Compared With Placebo With Nab-Paclitaxel as First-line Therapy for Patients With Primarily Diagnose or Recurrent and Metastatic Triple-Negative Breast Cancer

#### Organization Study ID Info
**ID:** NABP201801
#### Organization
**Class:** INDUSTRY
**Full Name:** CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2020-07-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2019-08-08

**Type:** ACTUAL

**Last Update Submit Date:** 2019-08-06

**Overall Status:** SUSPENDED

#### Primary Completion Date
**Date:** 2019-12-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2018-12-21

**Type:** ACTUAL

**Status Verified Date:** 2018-12

#### Study First Post Date
**Date:** 2018-12-17
**Type:** ACTUAL
**Study First Submit Date:** 2018-12-12
**Study First Submit QC Date:** 2018-12-13
**Why Stopped:** trial handovered to another sponser.
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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 Module

**Conditions:**

- Triple Negative Breast Cancer

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 375

**Type:** ESTIMATED

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

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

- Drug: Nab-Paclitaxel

**Label:** JS001 Plus Nab-Paclitaxel

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Intervention Names:**

- Drug: Nab-Paclitaxel

- Drug: Placebo

**Label:** Placebo Plus Nab-Paclitaxel

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- JS001 Plus Nab-Paclitaxel

**Description:** 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.

**Name:** JS001，an engineered anti-PD-1 antibody

**Other Names:**

- Terepril monoclonal antibody

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- JS001 Plus Nab-Paclitaxel

- Placebo Plus Nab-Paclitaxel

**Description:** 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.

**Name:** Nab-Paclitaxel

**Other Names:**

- Paclitaxel For Injection（Albumin Bound）

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Placebo Plus Nab-Paclitaxel

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

**Name:** Placebo

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Progression-Free Survival (PFS) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by Independent Review Committee (IRC)

**Time Frame:** From Day 1 to disease progression (PD) or death from any cause, assessed up to end of study (up to approximately 30 months)

#### Secondary Outcomes

**Description:** 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.

**Measure:** Progression-Free Survival (PFS) Assessed Using RECIST v1.1 by investigator

**Time Frame:** From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months)

**Description:** ORR is defined as the rate of CR or PR, as determined by IRC using RECIST v1.1 criteria.

**Measure:** Objective response rate (ORR) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by IRC

**Time Frame:** From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months)

**Description:** 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.

**Measure:** Duration of response (DoR) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by IRC

**Time Frame:** From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months)

**Description:** DCR is defined as the rate of of CR, PR, or stable disease according to RECIST v1.1.

**Measure:** Disease control rate (DCR) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)by IRC

**Time Frame:** From Day 1 to PD or death from any cause, assessed up to end of study (up to approximately 30 months)

**Description:** OS is defined as the time from randomization to death from any cause.

**Measure:** Overall Survival (OS)

**Time Frame:** From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)

**Description:** OS is defined as the time from randomization to death from any cause.

**Measure:** OS rate at 12 months

**Time Frame:** the percent of participants that are alive at 12months from Day 1.

**Description:** OS is defined as the time from randomization to death from any cause.

**Measure:** OS rate at 24 months

**Time Frame:** the percent of participants that are alive at 24 months from Day 1.

**Description:** 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.

**Measure:** PFS Assessed Using immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) by investigator

**Time Frame:** From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)

**Description:** ORR is defined as the rate of iCR or iPR, as determined by investigator using iRECIST criteria.

**Measure:** ORR Assessed Using immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) by investigator

**Time Frame:** From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)

**Description:** 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.

**Measure:** DoR Assessed Using immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) by investigator

**Time Frame:** From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)

**Description:** DCR is defined as the rate of of iCR, iPR, or stable disease according to iRECIST.

**Measure:** DCR Assessed Using immune-related Response Evaluation Criteria in Solid Tumors (iRECIST) by investigator

**Time Frame:** From Day 1 to death from any cause, assessed up to end of study (up to approximately 30 months)

**Description:** percentage and CTC AE(v5.0) of AEs

**Measure:** Percentage and severity of Participants With Adverse Events (AEs)

**Time Frame:** From Day 1 to 60 days after last dose of study drug, assessed up to end of study (up to approximately 30 months)

**Measure:** Percentage of Participants With Anti-Drug Antibodies (ATAs)

**Time Frame:** 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)

### Eligibility Module

**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.

**Maximum Age:** 70 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Beijing

**Country:** China

**Facility:** The fifth medical center of PLA general hospital

#### Overall Officials

**Official 1:**

**Affiliation:** Beijing 302 Hospital

**Name:** JIANG ZE FEI, PHD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000001941

- Term: Breast Diseases

- ID: D000012871

- Term: Skin Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M5220

- Name: Breast Neoplasms

- Relevance: HIGH

- As Found: Breast Cancer

- ID: M14850

- Name: Recurrence

- Relevance: LOW

- As Found: Unknown

- ID: M30373

- Name: Triple Negative Breast Neoplasms

- Relevance: HIGH

- As Found: Triple Negative Breast Cancer

- ID: M5218

- Name: Breast Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001943

- Term: Breast Neoplasms

- ID: D000064726

- Term: Triple Negative Breast Neoplasms

### Intervention Browse Module - Ancestors

- ID: D000000972

- Term: Antineoplastic Agents, Phytogenic

- ID: D000000970

- Term: Antineoplastic Agents

- ID: D000050257

- Term: Tubulin Modulators

- ID: D000050256

- Term: Antimitotic Agents

- ID: D000050258

- Term: Mitosis Modulators

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000007155

- Term: Immunologic Factors

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M19537

- Name: Paclitaxel

- Relevance: HIGH

- As Found: Surgery

- ID: M231

- Name: Albumin-Bound Paclitaxel

- Relevance: HIGH

- As Found: Surgery

- ID: M4225

- Name: Antibodies

- Relevance: HIGH

- As Found: Program

- ID: M4230

- Name: Antibodies, Monoclonal

- Relevance: LOW

- As Found: Unknown

- ID: M10184

- Name: Immunoglobulins

- Relevance: HIGH

- As Found: Program

- ID: M19117

- Name: Immunoglobulins, Intravenous

- Relevance: LOW

- As Found: Unknown

- ID: M26197

- Name: Tubulin Modulators

- Relevance: LOW

- As Found: Unknown

- ID: M26196

- Name: Antimitotic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000017239

- Term: Paclitaxel

- ID: D000068196

- Term: Albumin-Bound Paclitaxel

- ID: D000000906

- Term: Antibodies

- ID: D000007136

- Term: Immunoglobulins

### Misc Info Module

- Version Holder: 2024-05-24
