Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Triple Negative Breast Cancer (TNBC) | Triple-Negative Breast Carcinoma | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| B013+Nab-Paclitaxel | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- B013+ Nab-Paclitaxel
- 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.
- interventionNames
- Drug: B013+Nab-Paclitaxel
Primary outcomes (2)
- measure
- Objective response rate (ORR)(phase Ⅱ)
- timeFrame
- Baseline up to approximately 18 months
- description
- tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.
- measure
- Progression-free survival (PFS)(IRC) (phase Ⅲ)
- timeFrame
- Baseline up to approximately 18 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available