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
Status: Completed
Location: See all (13) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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)
Locations
Other Locations
China
Peking University Cancer Hospital
Beijing
Sichuan Cancer Hospital
Chengdu
Affiliated Cancer Hospital, Sun Yat-sen University
Guangzhou
Hainan cancer Hospital
Haikou
Zhejiang Cancer Hospital
Hangzhou
Huai'an First People's Hospital
Huai'an
Yunnan Cancer Hospital
Kunming
The First Affiliated Hospital of henan University of Science and Technoloy
Luoyang
Guangxi Medical University Cancer Hospital
Nanning
The second people's hospital of neijiang
Neijiang
Tianjin medical university cancer institute&hospital
Tianjin
Xiangyang Central Hospital
Xiangyang
The Central Hospital of Yongzhou
Yongzhou
Time Frame
Start Date: 2022-12-06
Completion Date: 2024-09-30
Participants
Target number of participants: 62
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Shanghai Jiaolian Drug Research and Development Co., Ltd
Collaborators: Shanghai Pharmaceuticals Holding Co., Ltd