NCT05555706CompletedPhase 2/3
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
Source: ClinicalTrials.gov · Last updated 15 Apr 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 62 (actual)
- First submitted
- 22 Sept 2022
- Start date
- 6 Dec 2022
- Primary completion date
- 30 Sept 2024
- Lead sponsor
- Shanghai Jiaolian Drug Research and Development Co., Ltd
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT05555706
What you commit to
- Study type: Interventional · Phase 2/3
- Participants enrolled: 62
- From 6 Dec 2022 to the primary completion date, 30 Sept 2024
- 13 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous treatment is eligible.
- Spinal cord compression not definitively treated with surgery and/or radiation prior to study entry
- Uncontrolled tumor-related pain prior to study entry
Other illness
- Known central nervous system (CNS) disease
- 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
Other
- Uncontrolled pleural effusion, pericardial effusion, or ascites Patients
- Pregnancy or lactation
Who the study is looking for
- 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)
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (13)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University Cancer Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Sichuan Cancer Hospital Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
| Affiliated Cancer Hospital, Sun Yat-sen University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
| Hainan Cancer Hospital Coordinator of this site? Confirm its status | Haikou | China | Unknown status |
| Zhejiang Cancer Hospital Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Huai'an First People's Hospital Coordinator of this site? Confirm its status | Huai'an | China | Unknown status |
| Yunnan Cancer Hospital Coordinator of this site? Confirm its status | Kunming | China | Unknown status |
| The First Affiliated Hospital of henan University of Science and Technoloy Coordinator of this site? Confirm its status | Luoyang | China | Unknown status |
| Guangxi Medical University Cancer Hospital Coordinator of this site? Confirm its status | Nanning | China | Unknown status |
| The Second People's Hospital of Neijiang Coordinator of this site? Confirm its status | Neijiang | China | Unknown status |
| Tianjin Medical University Cancer Institute & Hospital Coordinator of this site? Confirm its status | Tianjin | China | Unknown status |
| Xiangyang Central Hospital Coordinator of this site? Confirm its status | Xiangyang | China | Unknown status |
| The Central Hospital of Yongzhou Coordinator of this site? Confirm its status | Yongzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.