José Baselga
何塞·巴塞尔加
MD, PhD
Executive Vice President, Oncology R&D肿瘤研发执行副总裁
👥Biography 个人简介
José Baselga, MD, PhD was one of the most influential oncologists of his generation, renowned for his pioneering work on HER2-targeted therapy and early-phase clinical trials in breast and solid tumors. As Physician-in-Chief at Memorial Sloan Kettering Cancer Center and subsequently Chief Medical Officer at AstraZeneca, he bridged academic early-phase trial innovation with industry drug development at the highest level. Dr. Baselga led landmark phase I and II trials of trastuzumab, pertuzumab, and lapatinib in HER2-positive breast cancer, work that directly contributed to FDA approvals of these agents. He also led early-phase development of PI3K/AKT/mTOR pathway inhibitors, contributing foundational pharmacokinetic/pharmacodynamic data that informed the design of subsequent pivotal trials. His lab at Vall d'Hebron Institute of Oncology (VHIO) in Barcelona, which he co-founded, became a world-leading site for first-in-human trials. Dr. Baselga was instrumental in establishing RECIST criteria and novel response endpoints in early-phase trials, and championed the integration of serial tumor biopsies and pharmacodynamic biomarkers as mandatory correlative studies in phase I programs.
🧪Research Fields 研究领域
🎓Key Contributions 主要贡献
HER2-Targeted Therapy Phase I Development
Led seminal phase I and early-phase trials of trastuzumab and pertuzumab in HER2-positive breast cancer, establishing proof-of-concept for HER2 blockade and contributing pharmacokinetic and biomarker data essential to regulatory approval.
PI3K Inhibitor Early Clinical Development
Conducted foundational phase I trials of BKM120 (buparlisib) and other PI3K inhibitors, defining MTD, pharmacokinetics, and pharmacodynamic markers of PI3K pathway inhibition in solid tumors.
Vall d'Hebron Phase I Unit
Co-founded the Vall d'Hebron Institute of Oncology (VHIO) early-phase unit in Barcelona, establishing it as a leading European center for first-in-human trials with rigorous translational science integration.
Pharmacodynamic Biomarkers in Phase I
Championed mandatory serial tumor biopsies and blood-based pharmacodynamic assays in phase I trial protocols, enabling mechanism-of-action confirmation and early evidence of target engagement to inform dose selection.
Representative Works 代表性著作
Phase I study of the PI3K inhibitor BKM120 in patients with advanced solid tumors
Annals of Oncology (2012)
First-in-human phase I trial of the pan-PI3K inhibitor buparlisib, establishing MTD, PK/PD relationships, and early evidence of anti-tumor activity in PIK3CA-mutant tumors.
Pertuzumab plus trastuzumab for HER2-positive metastatic breast cancer: phase I study
Journal of Clinical Oncology (2010)
Phase I trial establishing safety, tolerability, and pharmacokinetics of combined pertuzumab and trastuzumab, providing the rationale for the pivotal CLEOPATRA phase III trial.
Everolimus in postmenopausal hormone-receptor–positive advanced breast cancer
New England Journal of Medicine (2012)
BOLERO-2 trial demonstrating significant PFS benefit of everolimus plus exemestane, building on phase I mTOR inhibitor development work.
🏆Awards & Recognition 奖项与荣誉
📄Data Sources 数据来源
Last updated: 2026-01-15 | All information from publicly available academic sources
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Sara M. Tolaney
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Carlos H. Barrios
PUCRS (Pontifical Catholic University of Rio Grande do Sul) / Hospital São Lucas, Porto Alegre, Brazil
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