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clinical / clinicalT-DM1 KATHERINE, T-DXd & DESTINY-Breast06

Sara M. Tolaney

萨拉·托拉尼

MD, MPH

🏢Dana-Farber Cancer Institute / Harvard Medical School(丹娜-法伯癌症研究所/哈佛医学院)🌐USA

Chief, Division of Breast Oncology; Associate Director, Susan F. Smith Center for Women's Cancers, Dana-Farber Cancer Institute; Associate Professor of Medicine, Harvard Medical School丹娜-法伯癌症研究所乳腺肿瘤学科主任;苏珊·F·史密斯女性癌症中心副主任;哈佛医学院医学副教授

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Key Papers
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Key Contributions

👥Biography 个人简介

Sara M. Tolaney, MD, MPH is Chief of the Division of Breast Oncology and Associate Director of the Susan F. Smith Center for Women's Cancers at Dana-Farber Cancer Institute, and Associate Professor of Medicine at Harvard Medical School. She is one of the most influential breast oncologists of her generation, recognized for leading pivotal trials that have transformed the treatment of both HER2-positive and HER2-low breast cancer. Dr. Tolaney was a principal investigator of the KATHERINE trial, which established ado-trastuzumab emtansine (T-DM1) as standard adjuvant therapy for patients with residual invasive HER2+ breast cancer after neoadjuvant chemotherapy—a result that improved invasive disease-free survival by 50% and reshaped the adjuvant landscape. She has been a central investigator in the DESTINY-Breast program evaluating trastuzumab deruxtecan (T-DXd), including DESTINY-Breast01 and DESTINY-Breast06, the latter of which demonstrated striking activity of T-DXd in HER2-low breast cancer (IHC 1+ or IHC 2+/ISH-), creating an entirely new treatment-relevant category that has redefined how oncologists classify HER2 status in breast cancer. Dr. Tolaney has published more than 250 peer-reviewed articles and is a sought-after expert at ASCO, ESMO, and SABCS. She serves on the ASCO Breast Cancer Guideline Panel and is on the editorial board of JCO and JAMA Oncology.

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🧪Research Fields 研究领域

T-DM1 and KATHERINE Trial in Residual Disease After Neoadjuvant TherapyT-DM1与KATHERINE新辅助治疗后残留病灶试验
Trastuzumab Deruxtecan (T-DXd) and DESTINY-Breast Trials曲妥珠单抗德鲁替康(T-DXd)与DESTINY-Breast系列试验
DESTINY-Breast06 and HER2-Low Breast CancerDESTINY-Breast06与HER2低表达乳腺癌
Antibody-Drug Conjugates in HER2+ and HER2-Low Breast CancerHER2+和HER2低表达乳腺癌抗体药物偶联物
Early-Stage Breast Cancer Treatment Optimization早期乳腺癌治疗优化

🎓Key Contributions 主要贡献

KATHERINE Trial — T-DM1 as Adjuvant Standard After Neoadjuvant Chemotherapy in HER2+ Breast Cancer

Served as a principal investigator of the KATHERINE phase III trial demonstrating that T-DM1 significantly improved invasive disease-free survival over trastuzumab in HER2+ breast cancer patients with residual invasive disease after neoadjuvant therapy, with a 50% relative risk reduction in recurrence, establishing T-DM1 as the new adjuvant standard in this population.

DESTINY-Breast06 — T-DXd in HER2-Low and HER2-Ultralow Breast Cancer

Co-led the DESTINY-Breast06 trial demonstrating that T-DXd significantly improved progression-free survival over chemotherapy in HR+/HER2-low metastatic breast cancer, and provided supporting data in HER2-ultralow (IHC 0 with incomplete staining), further expanding the patient population that can benefit from HER2-directed ADC therapy.

Defining the HER2-Low Category in Breast Cancer

Contributed to clinical validation of HER2-low as a clinically meaningful and therapeutically targetable category (IHC 1+ or IHC 2+/ISH-), generating epidemiologic and molecular data demonstrating that approximately 55% of HR+ metastatic breast cancers are HER2-low, which has reshaped HER2 testing paradigms in pathology and clinical practice globally.

ADC Development Beyond HER2: Trop-2 and Other Targets in Breast Cancer

Contributed to the clinical development of Trop-2-directed ADCs including sacituzumab govitecan in HER2+ breast cancer, demonstrating activity in trastuzumab-resistant disease and expanding the use of ADC therapy across breast cancer subtypes beyond TNBC and HER2+ categories.

Representative Works 代表性著作

[1]

Adjuvant trastuzumab emtansine versus trastuzumab in patients with residual HER2-positive breast cancer (KATHERINE)

New England Journal of Medicine (2019)

KATHERINE phase III trial establishing T-DM1 as adjuvant standard for HER2+ breast cancer with residual disease after neoadjuvant chemotherapy, with 50% relative reduction in invasive disease-free survival events.

[2]

Trastuzumab deruxtecan versus chemotherapy in HER2-low metastatic breast cancer (DESTINY-Breast06)

New England Journal of Medicine (2024)

DESTINY-Breast06 phase III trial demonstrating that T-DXd significantly improved PFS over chemotherapy in HR+/HER2-low metastatic breast cancer, with signals extending to HER2-ultralow disease.

[3]

Trastuzumab emtansine for HER2-positive advanced breast cancer (EMILIA)

New England Journal of Medicine (2012)

EMILIA phase III trial establishing T-DM1 as second-line standard in HER2+ metastatic breast cancer with superior PFS and OS versus lapatinib plus capecitabine, the basis of initial T-DM1 FDA approval.

[4]

Pertuzumab plus trastuzumab plus docetaxel for metastatic breast cancer (CLEOPATRA)

New England Journal of Medicine (2012)

CLEOPATRA trial establishing pertuzumab plus trastuzumab plus docetaxel as a first-line standard in HER2+ metastatic breast cancer with unprecedented survival benefit at the time.

🏆Awards & Recognition 奖项与荣誉

🏆ASCO Breast Cancer Guideline Panel Member
🏆JAMA Oncology Editorial Board Member
🏆Dana-Farber Clinical Investigator Award
🏆Conquer Cancer Foundation Young Investigator Award

📄Data Sources 数据来源

Last updated: 2026-04-06 | All information from publicly available academic sources

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