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Translational Medicine / 转化医学Breast Cancer & HER2

Hope Rugo

MD, FASCO

🏢UCSF Helen Diller Family Comprehensive Cancer Center🌐USA

Professor, Division of Hematology/Oncology; Director, Breast Oncology and Clinical Trials Education, UCSF Helen Diller Family Comprehensive Cancer Center

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Key Papers
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Awards
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Key Contributions

👥Biography 个人简介

Hope Rugo is a Professor and Director of Breast Oncology and Clinical Trials Education at the UCSF Helen Diller Family Comprehensive Cancer Center. She is recognized internationally as a leading expert in breast cancer clinical trials, with a particular focus on antibody-drug conjugates, trastuzumab and its biosimilars, and innovative clinical trial designs. Her work has been central to the clinical development of sacituzumab govitecan (Trodelvy), a Trop-2-directed ADC that transformed the treatment of metastatic TNBC and HR+ breast cancer. Rugo was a principal investigator on the ASCENT trial, which demonstrated significant survival benefit for sacituzumab govitecan versus single-agent chemotherapy in heavily pretreated metastatic TNBC, leading to full FDA approval. She has also led extensive work on trastuzumab biosimilar development, chairing or participating in multiple regulatory-enabling equivalence studies, and has become a leading expert on biosimilar adoption in oncology practice. In addition to her research, Rugo has made major contributions to supportive oncology, including studies on the management of chemotherapy-induced alopecia, nail toxicity, and dermatologic adverse events from targeted therapies. She is co-founder of the TBCRC (Translational Breast Cancer Research Consortium) and has helped build one of the nation's most productive breast cancer clinical trials programs.

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🧪Research Fields 研究领域

Sacituzumab govitecan
Trastuzumab biosimilars
Metastatic breast cancer
Antibody-drug conjugates
Breast cancer supportive care

🎓Key Contributions 主要贡献

Sacituzumab Govitecan in TNBC and HR+ Breast Cancer

Co-led the ASCENT trial demonstrating sacituzumab govitecan significantly improved overall survival versus chemotherapy in pretreated metastatic TNBC, and subsequently contributed to evaluation in HR+ disease, establishing a new ADC standard of care.

Trastuzumab Biosimilar Development

Led or participated in multiple pivotal equivalence trials for trastuzumab biosimilars including MYL-1401O and ABP 980, providing critical data supporting regulatory approvals that expand patient access to HER2-targeted therapy.

Innovative Clinical Trial Designs in Breast Cancer

Championed umbrella and basket trial designs for breast cancer, including the I-SPY2 platform trial, which uses adaptive randomization to efficiently identify active agents in TNBC and HR+ subtypes.

Supportive Care and Toxicity Management

Conducted research on preventing and managing treatment-related toxicities including chemotherapy-induced alopecia and scalp cooling, and dermatologic toxicities from CDK4/6 inhibitors and immunotherapy, improving patient quality of life.

Representative Works 代表性著作

[1]

Sacituzumab Govitecan in Metastatic Triple-Negative Breast Cancer (ASCENT)

New England Journal of Medicine (2021)

Demonstrated that sacituzumab govitecan significantly improved progression-free and overall survival versus single-agent chemotherapy in pretreated metastatic TNBC.

[2]

Efficacy and Safety of the Proposed Trastuzumab Biosimilar MYL-1401O versus Reference Trastuzumab: Results from the 48-Week Phase III HERITAGE Trial

Annals of Oncology (2017)

Established pharmacological equivalence and comparable clinical outcomes for a trastuzumab biosimilar in HER2+ metastatic breast cancer, supporting regulatory approval.

[3]

I-SPY 2: An Adaptive Breast Cancer Trial Design in the Setting of Neoadjuvant Chemotherapy

Clinical Pharmacology & Therapeutics (2013)

Described the design and rationale for the I-SPY2 adaptive platform trial, enabling efficient biomarker-driven screening of novel agents in early breast cancer.

🏆Awards & Recognition 奖项与荣誉

🏆ASCO Fellow (FASCO)
🏆UCSF Distinguished Clinician Investigator Award
🏆Susan G. Komen Foundation Scientific Advisory Council Member

📄Data Sources 数据来源

Last updated: 2026-04-05 | All information from publicly available academic sources

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