Trial Title:
Study of B013 and Nab-Paclitaxel for Locally Advanced or Metastatic Triple Negative Breast Cancer
NCT ID:
NCT05555706
Condition:
Triple Negative Breast Cancer (TNBC)
Conditions: Official terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Paclitaxel
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
B013+Nab-Paclitaxel
Description:
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.
Arm group label:
B013+ Nab-Paclitaxel
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).
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Affiliated Cancer Hospital, Sun Yat-sen University
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Shusen Wang
Phone:
0086-20-87343811
Email:
wangshs@sysucc.org.cn
Facility:
Name:
Guangxi Medical University Cancer Hospital
Address:
City:
Nanning
Zip:
530021
Country:
China
Status:
Recruiting
Contact:
Last name:
Yongkui Lu
Phone:
0086-0771-5330855
Email:
yuanban520@163.com
Facility:
Name:
Hainan cancer Hospital
Address:
City:
Haikou
Zip:
570312
Country:
China
Status:
Recruiting
Contact:
Last name:
Quchang Ouyang
Phone:
0086-0731-89762695
Email:
450766347@qq.com
Facility:
Name:
The First Affiliated Hospital of henan University of Science and Technoloy
Address:
City:
Luoyang
Zip:
450062
Country:
China
Status:
Recruiting
Contact:
Last name:
Xinshuai Wang
Phone:
0086-0379-64922216
Email:
Hkdyfyllb@163.com
Facility:
Name:
Xiangyang Central Hospital
Address:
City:
Xiangyang
Zip:
441021
Country:
China
Status:
Recruiting
Contact:
Last name:
Tienan Yi
Phone:
0086-0710-3511354
Email:
hbxyszxyy@163.com
Facility:
Name:
The Central Hospital of Yongzhou
Address:
City:
Yongzhou
Zip:
425002
Country:
China
Status:
Recruiting
Contact:
Last name:
Sijuan Ding
Phone:
0086-0746-8851096
Email:
yzllwyh@163.com
Facility:
Name:
Huai'an First People's Hospital
Address:
City:
Huai'an
Zip:
223300
Country:
China
Status:
Recruiting
Contact:
Last name:
Mingde Huang
Phone:
0086-0517-84936880
Facility:
Name:
Sichuan Cancer Hospital
Address:
City:
Chengdu
Zip:
610041
Country:
China
Status:
Recruiting
Contact:
Last name:
Hui Li
Phone:
0086-028 85420305
Email:
moulinlin@sphchina.com
Facility:
Name:
The second people's hospital of neijiang
Address:
City:
Neijiang
Zip:
641199
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Xujuan Wang
Phone:
0086-0832-2380274
Email:
nj2h@schinfo.net
Facility:
Name:
Yunnan Cancer Hospital
Address:
City:
Kunming
Zip:
650118
Country:
China
Status:
Recruiting
Contact:
Last name:
Jianyun Nie
Phone:
0086-0871-68179625
Email:
ynzlyyll@163.com
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Zip:
310005
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhanhong Chen
Phone:
0086-0571-88122146
Email:
irb@zjcc.org.cn
Facility:
Name:
Peking University Cancer Hospital
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Contact:
Last name:
Huiping Li
Phone:
0086-10-88121122
Email:
huipingli2012@hotmail.com
Facility:
Name:
Tianjin medical university cancer institute&hospital
Address:
City:
Tianjin
Zip:
300060
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhongsheng Tong
Phone:
0086-022-23340123
Email:
ec_tjcih@126.com
Start date:
December 6, 2022
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Shanghai Jiaolian Drug Research and Development Co., Ltd
Agency class:
Industry
Collaborator:
Agency:
Shanghai Pharmaceuticals Holding Co., Ltd
Agency class:
Industry
Source:
Shanghai Jiaolian Drug Research and Development Co., Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05555706
