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

Primary Purpose

Triple Negative Breast Cancer (TNBC)

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
B013+Nab-Paclitaxel
Sponsored by
Shanghai Jiaolian Drug Research and Development Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Triple Negative Breast Cancer (TNBC)

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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. Prior treatment with anti-ROR1 or anti-Wnt5a therapeutic antibodies
  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

Sites / Locations

  • Affiliated Cancer Hospital, Sun Yat-sen UniversityRecruiting
  • Guangxi Medical University Cancer HospitalRecruiting
  • Hainan cancer HospitalRecruiting
  • The First Affiliated Hospital of henan University of Science and TechnoloyRecruiting
  • Xiangyang Central HospitalRecruiting
  • The Central Hospital of YongzhouRecruiting
  • Huai'an First People's HospitalRecruiting
  • Sichuan Cancer HospitalRecruiting
  • The second people's hospital of neijiang
  • Yunnan Cancer HospitalRecruiting
  • Zhejiang Cancer HospitalRecruiting
  • Peking University Cancer HospitalRecruiting
  • Tianjin medical university cancer institute&hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

B013+ Nab-Paclitaxel

Arm 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.

Outcomes

Primary Outcome Measures

Objective response rate (ORR)(phase Ⅱ)
tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.
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.

Secondary Outcome Measures

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

Full Information

First Posted
September 22, 2022
Last Updated
June 5, 2023
Sponsor
Shanghai Jiaolian Drug Research and Development Co., Ltd
Collaborators
Shanghai Pharmaceuticals Holding Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05555706
Brief Title
Study of B013 and Nab-Paclitaxel for Locally Advanced or Metastatic Triple Negative Breast Cancer
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 6, 2022 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Jiaolian Drug Research and Development Co., Ltd
Collaborators
Shanghai Pharmaceuticals Holding Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Triple Negative Breast Cancer (TNBC)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
B013+ Nab-Paclitaxel
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
B013+Nab-Paclitaxel
Intervention 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.
Primary Outcome Measure Information:
Title
Objective response rate (ORR)(phase Ⅱ)
Description
tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.
Time Frame
Baseline up to approximately 18 months
Title
Progression-free survival (PFS)(IRC) (phase Ⅲ)
Description
from the start date of study treatment to the date of progression disease or death , whichever occurred first.
Time Frame
Baseline up to approximately 18 months
Secondary Outcome Measure Information:
Title
Disease control rate (DCR)
Description
DCR was defined as the percentage of patients who have achieved complete response, partial response and stable disease
Time Frame
18 months
Title
Duration of remission (DOR)
Description
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
Time Frame
18 months
Title
Time to Response (TTR)
Description
Defined as the interval from the start of study therapy to the first documentation of an objective response
Time Frame
18 months
Title
Overall Survival (OS)
Description
Determination of the overall survival times of all patients
Time Frame
3years
Title
Drug concentration in plasma
Description
Determination of drug concentration in plasma of all patients
Time Frame
18 months
Title
Incidence of Treatment-Emergent Adverse Events
Description
Adverse event type, incidence, duration, correlation with study drug
Time Frame
3years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shusen Wang
Phone
0086-20-87343811
Email
wangshs@sysucc.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shusen Wang
Organizational Affiliation
Affiliated Cancer Hospital, Sun Yat-sen University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Huiping Li
Organizational Affiliation
Peking University Cancer Hospital & Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Affiliated Cancer Hospital, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shusen Wang
Phone
0086-20-87343811
Email
wangshs@sysucc.org.cn
Facility Name
Guangxi Medical University Cancer Hospital
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongkui Lu
Phone
0086-0771-5330855
Email
yuanban520@163.com
Facility Name
Hainan cancer Hospital
City
Haikou
State/Province
Hainan
ZIP/Postal Code
570312
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Quchang Ouyang
Phone
0086-0731-89762695
Email
450766347@qq.com
Facility Name
The First Affiliated Hospital of henan University of Science and Technoloy
City
Luoyang
State/Province
Henan
ZIP/Postal Code
450062
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinshuai Wang
Phone
0086-0379-64922216
Email
Hkdyfyllb@163.com
Facility Name
Xiangyang Central Hospital
City
Xiangyang
State/Province
Hubei
ZIP/Postal Code
441021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tienan Yi
Phone
0086-0710-3511354
Email
hbxyszxyy@163.com
Facility Name
The Central Hospital of Yongzhou
City
Yongzhou
State/Province
Hunan
ZIP/Postal Code
425002
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sijuan Ding
Phone
0086-0746-8851096
Email
yzllwyh@163.com
Facility Name
Huai'an First People's Hospital
City
Huai'an
State/Province
Jiangsu
ZIP/Postal Code
223300
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mingde Huang
Phone
0086-0517-84936880
Facility Name
Sichuan Cancer Hospital
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui Li
Phone
0086-028 85420305
Email
moulinlin@sphchina.com
Facility Name
The second people's hospital of neijiang
City
Neijiang
State/Province
Sichuan
ZIP/Postal Code
641199
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xujuan Wang
Phone
0086-0832-2380274
Email
nj2h@schinfo.net
Facility Name
Yunnan Cancer Hospital
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650118
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianyun Nie
Phone
0086-0871-68179625
Email
ynzlyyll@163.com
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310005
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhanhong Chen
Phone
0086-0571-88122146
Email
irb@zjcc.org.cn
Facility Name
Peking University Cancer Hospital
City
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huiping Li
Phone
0086-10-88121122
Email
huipingli2012@hotmail.com
Facility Name
Tianjin medical university cancer institute&hospital
City
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhongsheng Tong
Phone
0086-022-23340123
Email
ec_tjcih@126.com

12. IPD Sharing Statement

Learn more about this trial

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

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