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

Shanghai Jiaolian Drug Research and Development

Status and phase: Completed; Phase 3; Phase 2

Conditions: Triple Negative Breast Cancer (TNBC)

Treatments: Drug: B013+Nab-Paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT05555706

B013-301

Details and patient eligibility

About

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).

Enrollment: 62 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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62 participants in 1 patient group

B013+ Nab-Paclitaxel

Experimental group

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.

Treatment:

Drug: B013+Nab-Paclitaxel