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

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

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).

Study Overview

• Status: Completed
• Conditions: Triple Negative Breast Cancer (TNBC)
• Intervention / Treatment: Drug: B013+Nab-Paclitaxel

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100142
    • Peking University Cancer Hospital
  • Tianjin, China, 300060
    • Tianjin Medical University Cancer Institute&Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Affiliated Cancer Hospital, Sun Yat-sen University
  • Guangxi
    • Nanning, Guangxi, China, 530021
      • Guangxi Medical University Cancer Hospital
  • Hainan
    • Haikou, Hainan, China, 570312
      • Hainan Cancer Hospital
  • Henan
    • Luoyang, Henan, China, 450062
      • The First Affiliated Hospital of henan University of Science and Technoloy
  • Hubei
    • Xiangyang, Hubei, China, 441021
      • Xiangyang Central Hospital
  • Hunan
    • Yongzhou, Hunan, China, 425002
      • The Central Hospital of Yongzhou
  • Jiangsu
    • Huai'an, Jiangsu, China, 223300
      • Huai'an First People's Hospital
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • Sichuan Cancer Hospital
    • Neijiang, Sichuan, China, 641199
      • The Second People's Hospital of Neijiang
  • Yunnan
    • Kunming, Yunnan, China, 650118
      • Yunnan Cancer Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310005
      • Zhejiang Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (ORR)(phase Ⅱ)	tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.	Baseline up to approximately 18 months
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.	Baseline up to approximately 18 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shanghai Jiaolian Drug Research and Development Co., Ltd
• Collaborators: Shanghai Pharmaceuticals Holding Co., Ltd
• Investigators: Principal Investigator: Shusen Wang, Affiliated Cancer Hospital, Sun Yat-sen University; Principal Investigator: Huiping Li, Peking University Cancer Hospital & Institute

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2022
• Primary Completion (Actual): September 30, 2024
• Study Completion (Actual): September 30, 2024

Study Registration Dates

• First Submitted: September 22, 2022
• First Submitted That Met QC Criteria: September 22, 2022
• First Posted (Actual): September 27, 2022

Study Record Updates

• Last Update Posted (Actual): April 15, 2025
• Last Update Submitted That Met QC Criteria: April 14, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms; Triple Negative Breast Neoplasms; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Paclitaxel
• Other Study ID Numbers: B013-301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No