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clinical / clinicalearly phase trials

José Baselga

何塞·巴塞尔加

MD, PhD

🏢AstraZeneca Oncology R&D (formerly Memorial Sloan Kettering Cancer Center)(阿斯利康肿瘤研发部(前纪念斯隆凯特琳癌症中心))🌐USA

Executive Vice President, Oncology R&D肿瘤研发执行副总裁

80
h-index
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Key Papers
4
Awards
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Key Contributions

👥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.

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🧪Research Fields 研究领域

Phase I TrialsI期临床试验
HER2-Targeted TherapyHER2靶向治疗
Breast Cancer Drug Development乳腺癌药物开发
PI3K InhibitorsPI3K抑制剂
First-in-Human Studies首次人体试验
Translational Oncology转化肿瘤学

🎓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

[1]

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.

[2]

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.

[3]

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

🏆ASCO David A. Karnofsky Memorial Award
🏆AACR Award for Outstanding Achievement in Chemistry and Cancer Research
🏆American Cancer Society Medal of Honor
🏆Elected Member, National Academy of Medicine (USA)

📄Data Sources 数据来源

Last updated: 2026-01-15 | All information from publicly available academic sources

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