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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Triple Negative Breast Cancer (TNBC)

Intervention / Treatment
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* Drug: B013+Nab-Paclitaxel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: B013+ Nab-Paclitaxel<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (ORR)(phase Ⅱ) | 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) | 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease control rate (DCR) | DCR was defined as the percentage of patients who have achieved complete response, partial response and stable disease | 18 months | 
| Duration of remission (DOR) | 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) | Defined as the interval from the start of study therapy to the first documentation of an objective response | 18 months | 
| Overall Survival (OS) | Determination of the overall survival times of all patients | 3years | 
| Drug concentration in plasma | Determination of drug concentration in plasma of all patients | 18 months | 
| Incidence of Treatment-Emergent Adverse Events | Adverse event type, incidence, duration, correlation with study drug | 3years |