Triple Negative Breast Cancer (TNBC)
Conditions
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).
Interventions
DRUGB013+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.
Sponsors
Shanghai Pharmaceuticals Holding Co., Ltd
Shanghai Jiaolian Drug Research and Development Co., Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Disease control rate (DCR) | 18 months | DCR was defined as the percentage of patients who have achieved complete response, partial response and stable disease |
| Incidence of Treatment-Emergent Adverse Events | 3years | Adverse event type, incidence, duration, correlation with study drug |
| 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 |
Countries
China
Outcome results
None listed