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

Phase 2

Completed

• Conditions: Triple Negative Breast Cancer (TNBC)
• Interventions: Drug: B013+Nab-Paclitaxel

• Registration Number: NCT05555706
• Lead Sponsor: Shanghai Jiaolian Drug Research and Development Co., Ltd

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-09-22
• Study First Submitted QC: 2022-09-22
• Study First Posted: 2022-09-27
• Study Start: 2022-12-06
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
B013+ Nab-Paclitaxel	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.

Primary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)(IRC) (phase Ⅲ)	Baseline up to approximately 18 months	from the start date of study treatment to the date of progression disease or death , whichever occurred first.
Objective response rate (ORR)(phase Ⅱ)	Baseline up to approximately 18 months	tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.

Secondary Outcome Measures

Name	Time	Method
Time to Response (TTR)	18 months	Defined as the interval from the start of study therapy to the first documentation of an objective response
Overall Survival (OS)	3years	Determination of the overall survival times of all patients
Drug concentration in plasma	18 months	Determination of drug concentration in plasma of all patients
Duration of remission (DOR)	18 months	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
Incidence of Treatment-Emergent Adverse Events	3years	Adverse event type, incidence, duration, correlation with study drug
Disease control rate (DCR)	18 months	DCR was defined as the percentage of patients who have achieved complete response, partial response and stable disease

Trial Locations

Locations (13)

Affiliated Cancer Hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China

Xiangyang Central Hospital; 🇨🇳 Xiangyang, Hubei, China

The second people's hospital of neijiang; 🇨🇳 Neijiang, Sichuan, China

Guangxi Medical University Cancer Hospital; 🇨🇳 Nanning, Guangxi, China

The Central Hospital of Yongzhou; 🇨🇳 Yongzhou, Hunan, China

Hainan cancer Hospital; 🇨🇳 Haikou, Hainan, China

The First Affiliated Hospital of henan University of Science and Technoloy; 🇨🇳 Luoyang, Henan, China

Huai'an First People's Hospital; 🇨🇳 Huai'an, Jiangsu, China

Sichuan Cancer Hospital; 🇨🇳 Chengdu, Sichuan, China

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China

Peking University Cancer Hospital; 🇨🇳 Beijing, China

Yunnan Cancer Hospital; 🇨🇳 Kunming, Yunnan, China

Tianjin medical university cancer institute&hospital; 🇨🇳 Tianjin, China