Study of B013 and Nab-Paclitaxel for Locally Advanced or Metastatic Triple Negative Breast Cancer

April 14, 2025 updated by: Shanghai Jiaolian Drug Research and Development Co., Ltd

A Phase II/III Study to Evaluate the Efficacy and Safety of B013 in Combination With Nab-Paclitaxel in First-line Treatment for Patients With Previously Untreated Locally Advanced or Metastatic Triple Negative Breast Cancer

This Phase II/III study assessed the efficacy, safety, pharmacokinetics, and immunogenicity of B013 administered with nab-paclitaxel in participants with locally advanced or metastatic triple negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic breast cancer (mBC).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Beijing, China, 100142
        • Peking University Cancer Hospital
      • Tianjin, China, 300060
        • Tianjin Medical University Cancer Institute＆Hospital
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Affiliated Cancer Hospital, Sun Yat-sen University
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Guangxi Medical University Cancer Hospital
    • Hainan
      • Haikou, Hainan, China, 570312
        • Hainan Cancer Hospital
    • Henan
      • Luoyang, Henan, China, 450062
        • The First Affiliated Hospital of henan University of Science and Technoloy
    • Hubei
      • Xiangyang, Hubei, China, 441021
        • Xiangyang Central Hospital
    • Hunan
      • Yongzhou, Hunan, China, 425002
        • The Central Hospital of Yongzhou
    • Jiangsu
      • Huai'an, Jiangsu, China, 223300
        • Huai'an first people's hospital
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Sichuan Cancer Hospital
      • Neijiang, Sichuan, China, 641199
        • The Second People's Hospital of Neijiang
    • Yunnan
      • Kunming, Yunnan, China, 650118
        • Yunnan Cancer Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310005
        • Zhejiang Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Women or men aged 18 -75 years
  2. Locally advanced or metastatic triple negative breast cancer (TNBC)
  3. No prior chemotherapy or targeted systemic therapy for inoperable locally advanced or metastatic TNBC
  4. ECOG performance status of 0 or 1
  5. Patient must have measurable or evaluable disease as defined by RECIST v1.1. Measurable lesions will be confirmed by radiographic imaging (CT or MRI)

Exclusion Criteria:

  1. Previous treatment is eligible.
  2. Spinal cord compression not definitively treated with surgery and/or radiation prior to study entry
  3. Known central nervous system (CNS) disease
  4. Uncontrolled pleural effusion, pericardial effusion, or ascites Patients
  5. Uncontrolled tumor-related pain prior to study entry
  6. The patient has a history of another malignancy within 5 years prior to study entry, except adequately treated non-melanotic skin cancer, carcinoma in situ of the cervix or Papillary carcinoma of the thyroid
  7. Pregnancy or lactation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: B013+ Nab-Paclitaxel

B013 at a fixed dose of 600 milligrams via intravenous (IV) infusion on Days 1 and 15 of the first 28-day cycle, then on Day 1 of each subsequent 28-day cycle.

Nab-Paclitaxel 100 mg/m^2 is administered weekly on Days 1, 8, 15 of each 28-day cycle.
Drug: B013+Nab-Paclitaxel

B013 at a fixed dose of 600 milligrams via intravenous (IV) infusion on Days 1 and 15 of the first 28-day cycle, then on Day 1 of each subsequent 28-day cycle.

Nab-Paclitaxel 100 mg/m^2 is administered weekly on Days 1, 8, 15 of each 28-day cycle.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)(phase Ⅱ)
Time Frame: Baseline up to approximately 18 months
tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.
Baseline up to approximately 18 months
Progression-free survival (PFS)(IRC) (phase Ⅲ)
Time Frame: Baseline up to approximately 18 months
from the start date of study treatment to the date of progression disease or death , whichever occurred first.
Baseline up to approximately 18 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Disease control rate (DCR)
Time Frame: 18 months
DCR was defined as the percentage of patients who have achieved complete response, partial response and stable disease
18 months
Duration of remission (DOR)
Time Frame: 18 months
DOR was defined for participants who had an objective response as the time from the first occurrence of a documented unconfirmed response (CR or PR) to the date of disease progression per RECIST v1.1 or death from any cause
18 months
Time to Response (TTR)
Time Frame: 18 months
Defined as the interval from the start of study therapy to the first documentation of an objective response
18 months
Overall Survival (OS)
Time Frame: 3years
Determination of the overall survival times of all patients
3years
Drug concentration in plasma
Time Frame: 18 months
Determination of drug concentration in plasma of all patients
18 months
Incidence of Treatment-Emergent Adverse Events
Time Frame: 3years
Adverse event type, incidence, duration, correlation with study drug
3years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai Jiaolian Drug Research and Development Co., Ltd

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Shanghai Pharmaceuticals Holding Co., Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shusen Wang, Affiliated Cancer Hospital, Sun Yat-sen University
  • Principal Investigator: Huiping Li, Peking University Cancer Hospital & Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 6, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 22, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 27, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B013-301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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