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Completed

NCT Number: NCT05555706

Study of B013 and Nab-Paclitaxel for 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).

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Key information

Conditions

Triple Negative Breast Cancer (TNBC) Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Triple Negative Breast Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Affiliated Cancer Hospital, Sun Yat-sen University, Guangzhou, Guangdong, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women or men aged 18 -75 years
  • Locally advanced or metastatic triple negative breast cancer (TNBC)
  • No prior chemotherapy or targeted systemic therapy for inoperable locally advanced or metastatic TNBC
  • ECOG performance status of 0 or 1
  • 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

  • Previous treatment is eligible.
  • Spinal cord compression not definitively treated with surgery and/or radiation prior to study entry
  • Known central nervous system (CNS) disease
  • Uncontrolled pleural effusion, pericardial effusion, or ascites Patients
  • Uncontrolled tumor-related pain prior to study entry
  • 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
  • Pregnancy or lactation

Treatment and study plan

B013+Nab-Paclitaxel

Drug

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. Overall Survival (OS)

    Time frame: 3years

    Determination of the overall survival times of all patients

  5. Drug concentration in plasma

    Time frame: 18 months

    Determination of drug concentration in plasma of all patients

  6. Incidence of Treatment-Emergent Adverse Events

    Time frame: 3years

    Adverse event type, incidence, duration, correlation with study drug

Sponsors and collaborators

Lead sponsor

Shanghai Jiaolian Drug Research and Development Co., Ltd

Industry

Collaborators

  • Shanghai Pharmaceuticals Holding Co., Ltd

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 27, 2022
Registry last updated
Apr 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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