Study of B013 and Nab-Paclitaxel for Locally Advanced or Metastatic Triple Negative Breast Cancer
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
1 other identifier
interventional
62
1 country
13
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2022
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 22, 2022
CompletedFirst Posted
Study publicly available on registry
September 27, 2022
CompletedStudy Start
First participant enrolled
December 6, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2024
CompletedApril 15, 2025
January 1, 2025
1.8 years
September 22, 2022
April 14, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (6)
Disease control rate (DCR)
18 months
Duration of remission (DOR)
18 months
Time to Response (TTR)
18 months
Overall Survival (OS)
3years
Drug concentration in plasma
18 months
- +1 more secondary outcomes
Study Arms (1)
B013+ Nab-Paclitaxel
EXPERIMENTALB013 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Affiliated Cancer Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510060, China
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, 530021, China
Hainan cancer Hospital
Haikou, Hainan, 570312, China
The First Affiliated Hospital of henan University of Science and Technoloy
Luoyang, Henan, 450062, China
Xiangyang Central Hospital
Xiangyang, Hubei, 441021, China
The Central Hospital of Yongzhou
Yongzhou, Hunan, 425002, China
Huai'an First People's Hospital
Huai'an, Jiangsu, 223300, China
Sichuan Cancer Hospital
Chengdu, Sichuan, 610041, China
The second people's hospital of neijiang
Neijiang, Sichuan, 641199, China
Yunnan Cancer Hospital
Kunming, Yunnan, 650118, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310005, China
Peking University Cancer Hospital
Beijing, 100142, China
Tianjin medical university cancer institute&hospital
Tianjin, 300060, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shusen Wang
Affiliated Cancer Hospital, Sun Yat-sen University
- PRINCIPAL INVESTIGATOR
Huiping Li
Peking University Cancer Hospital & Institute
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 22, 2022
First Posted
September 27, 2022
Study Start
December 6, 2022
Primary Completion
September 30, 2024
Study Completion
September 30, 2024
Last Updated
April 15, 2025
Record last verified: 2025-01