Study of B013 and Nab-Paclitaxel for Locally Advanced or Metastatic Triple Negative Breast Cancer
NCT ID: NCT05555706
Last Updated: 2025-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
62 participants
INTERVENTIONAL
2022-12-06
2024-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
75 Years
ALL
No
Sponsors
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Shanghai Pharmaceuticals Holding Co., Ltd
INDUSTRY
Shanghai Jiaolian Drug Research and Development Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Shusen Wang
Role: PRINCIPAL_INVESTIGATOR
Affiliated Cancer Hospital, Sun Yat-sen University
Huiping Li
Role: PRINCIPAL_INVESTIGATOR
Peking University Cancer Hospital & Institute
Locations
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Affiliated Cancer Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China
Hainan cancer Hospital
Haikou, Hainan, China
The First Affiliated Hospital of henan University of Science and Technoloy
Luoyang, Henan, China
Xiangyang Central Hospital
Xiangyang, Hubei, China
The Central Hospital of Yongzhou
Yongzhou, Hunan, China
Huai'an First People's Hospital
Huai'an, Jiangsu, China
Sichuan Cancer Hospital
Chengdu, Sichuan, China
The second people's hospital of neijiang
Neijiang, Sichuan, China
Yunnan Cancer Hospital
Kunming, Yunnan, China
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China
Peking University Cancer Hospital
Beijing, , China
Tianjin medical university cancer institute&hospital
Tianjin, , China
Countries
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Other Identifiers
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B013-301
Identifier Type: -
Identifier Source: org_study_id
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