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Brief Title: Study of B013 and Nab-Paclitaxel for Locally Advanced or Metastatic Triple Negative Breast Cancer
Official Title: 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
Study ID: NCT05555706
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).
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Name: Shusen Wang
Affiliation: Affiliated Cancer Hospital, Sun Yat-sen University
Role: PRINCIPAL_INVESTIGATOR
Name: Huiping Li
Affiliation: Peking University Cancer Hospital & Institute
Role: PRINCIPAL_INVESTIGATOR