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

Triple Negative Breast Cancer (TNBC) Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05555706
• Other study ID #: B013-301
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: December 6, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: November 2023
• Source: Shanghai Jiaolian Drug Research and Development Co., Ltd
• Contact: Shusen Wang
• Phone: 0086-20-87343811
• Email: wangshs[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: December 31, 2026
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Triple Negative Breast Cancer (TNBC)
• Triple Negative Breast Neoplasms

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Peking University Cancer Hospital	Beijing
China	Sichuan Cancer Hospital	Chengdu	Sichuan
China	Affiliated Cancer Hospital, Sun Yat-sen University	Guangzhou	Guangdong
China	Hainan cancer Hospital	Haikou	Hainan
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Huai'an First People's Hospital	Huai'an	Jiangsu
China	Yunnan Cancer Hospital	Kunming	Yunnan
China	The First Affiliated Hospital of henan University of Science and Technoloy	Luoyang	Henan
China	Guangxi Medical University Cancer Hospital	Nanning	Guangxi
China	The second people's hospital of neijiang	Neijiang	Sichuan
China	Tianjin medical university cancer institute&hospital	Tianjin
China	Xiangyang Central Hospital	Xiangyang	Hubei
China	The Central Hospital of Yongzhou	Yongzhou	Hunan

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Jiaolian Drug Research and Development Co., Ltd	Shanghai Pharmaceuticals Holding Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate (ORR)(phase ?)	tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.	Baseline up to approximately 18 months
Primary	Progression-free survival (PFS)(IRC) (phase ?)	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	Disease control rate (DCR)	DCR was defined as the percentage of patients who have achieved complete response, partial response and stable disease	18 months
Secondary	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
Secondary	Time to Response (TTR)	Defined as the interval from the start of study therapy to the first documentation of an objective response	18 months
Secondary	Overall Survival (OS)	Determination of the overall survival times of all patients	3years
Secondary	Drug concentration in plasma	Determination of drug concentration in plasma of all patients	18 months
Secondary	Incidence of Treatment-Emergent Adverse Events	Adverse event type, incidence, duration, correlation with study drug	3years