Sara Tolaney

Sara Tolaney

Medical Oncologist

Breast Oncology

Dana-Farber Cancer Institute

Location USA, Boston

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Dr. Sara M. Tolaney is Chief of the Division of Breast Oncology at Dana-Farber Cancer Institute and Associate Professor of Medicine at Harvard Medical School. A breast medical oncologist with a focus on the development of novel therapies, she has been instrumental in advancing treatment approaches for breast cancer across multiple areas, including de-escalation strategies for early-stage HER2-positive disease, CDK4/6 inhibitors, antibody-drug conjugates, and immunotherapy. She developed the paclitaxel and trastuzumab (APT) regimen for low-risk early HER2-positive breast cancer — now incorporated into national and international treatment guidelines — and served as international co-PI for the first randomized study of CDK4/6 inhibitors in HER2-positive breast cancer. She is a member of the NCI Breast Cancer Steering Committee, Vice Chair for Late-Stage Development in Breast Cancer in the Alliance for Clinical Trials in Oncology, and chairs multiple phase 3 trials in breast cancer. Her research has been funded by the Breast Cancer Research Foundation and Susan G. Komen. She received her undergraduate degree from Princeton University in 1998, her MD from UC San Francisco in 2002, completed residency at Johns Hopkins University and fellowship at Dana-Farber Cancer Institute, and obtained a Master of Public Health from the Harvard School of Public Health in 2007. She has been recognized with the Lee Nadler Extra Mile Award for outstanding patient care.

Current Positions

  • Chief, Division of Breast Oncology, Susan F. Smith Center for Women’s Cancers, Dana-Farber Cancer Institute
  • Associate Director, Susan F. Smith Center for Women’s Cancers, Dana-Farber Cancer Institute, July 2016–present
  • Director, Clinical Trials, Breast Oncology, Dana-Farber Cancer Institute, 2016–present
  • Senior Physician, Dana-Farber Cancer Institute
  • Associate Professor of Medicine, Harvard Medical School, July 2020–present
  • Member, NCI Breast Cancer Steering Committee
  • Vice Chair, Late-Stage Development in Breast Cancer, Alliance for Clinical Trials in Oncology

Education

  • A.B., Chemistry, Princeton University, 1994–1998
  • MD, Medicine, UC San Francisco School of Medicine, 1998–2002
  • Master of Public Health (MPH), Harvard School of Public Health, 2006–2007

Postgraduate Training

  • Residency, Internal Medicine, Johns Hopkins Hospital, 2002–2005
  • Fellowship, Hematology and Oncology, Dana-Farber Cancer Institute / Partners CancerCare, 2005–2008

Board Certifications

  • Hematology
  • Internal Medicine
  • Medical Oncology

Research Activity

  • HER2-positive early breast cancer and de-escalation: Principal investigator of the APT trial (paclitaxel and trastuzumab for node-negative HER2-positive breast cancer) — a landmark study whose 10-year results were published in The Lancet Oncology (2023, 202 citations) and which established a less-toxic regimen now incorporated into national and international guidelines; lead investigator of the ATEMPT trial comparing adjuvant T-DM1 versus paclitaxel/trastuzumab for stage I HER2-positive breast cancer (Journal of Clinical Oncology, 2021; 5-year results JCO, 2024)
  • CDK4/6 inhibitors: International co-PI for the first randomized study of CDK4/6 inhibitors in HER2-positive breast cancer (monarcHER, The Lancet Oncology, 2020, 290 citations); served on the steering committee for monarchE leading to the first adjuvant CDK4/6 inhibitor approval; contributed to MONARCH 1 (Clinical Cancer Research, 2017, 830 citations), MONARCH 3 (Annals of Oncology, 2024, 220 citations), and PACE (Journal of Clinical Oncology, 2024, 130 citations)
  • Antibody-drug conjugates: Led multiple registration trials including ASCENT (sacituzumab govitecan in metastatic TNBC, NEJM, 2021, 1920 citations; TROPiCS-02 in HR+/HER2− breast cancer, The Lancet, 2023, 502 citations); principal investigator of NeoSTAR (neoadjuvant sacituzumab govitecan in localized TNBC, Annals of Oncology, 2024); led the DESTINY-Breast trial program including trastuzumab deruxtecan plus pertuzumab in HER2-positive metastatic breast cancer (NEJM, 2026, 54 citations); co-investigator on ATEZO-BREAST and ASCENT-04 programs
  • Immunotherapy: Developed a series of investigator-initiated clinical trials in immunotherapy with strong translational endpoints, including TOPACIO/Keynote-162 (niraparib plus pembrolizumab in TNBC, JAMA Oncology, 2019, 474 citations), ENHANCE 1 (eribulin plus pembrolizumab in TNBC, Clinical Cancer Research, 2021, 124 citations), NIMBUS (nivolumab plus ipilimumab in hypermutated HER2-negative metastatic breast cancer, Nature Communications, 2025), and multiple pembrolizumab combination trials; co-investigator on leptomeningeal carcinomatosis pembrolizumab trial (Nature Medicine, 2020, 161 citations)
  • HER2-low breast cancer: Key contributor to defining the HER2-low paradigm; co-authored the landmark landscape paper in Journal of Clinical Oncology (2020, 911 citations) and ESMO expert consensus statements on HER2-low breast cancer (Annals of Oncology, 2023, 402 citations); led multiple real-world and translational studies characterizing HER2-low biology and outcomes
  • Biomarker research and liquid biopsy: Co-investigator on multiple liquid biopsy studies examining circulating tumor DNA, cell-free DNA, and genomic landscape of resistance to CDK4/6 inhibitors and HER2-directed therapies
  • Translational immunology: Studies on the immune microenvironment in HR-positive and triple-negative breast cancer, tumor-infiltrating lymphocytes, and mechanisms of response and resistance to immunotherapy
  • Sacituzumab govitecan and TROP2-directed therapy: Led the SACI-IO program; co-investigator on OptimICE-RD and ASCENT-05; chairs multiple phase 3 programs
  • Research funding: Funded by the Breast Cancer Research Foundation and Susan G. Komen

 Memberships / Affiliations / Honors

  • Member, NCI Breast Cancer Steering Committee
  • Vice Chair, Late-Stage Development in Breast Cancer, Alliance for Clinical Trials in Oncology
  • American Society of Clinical Oncology (ASCO)
  • Breast Cancer Research Foundation — funded investigator
  • Susan G. Komen — funded investigator
  • Lee Nadler Extra Mile Award for outstanding patient care, Dana-Farber Cancer Institute

Areas of Specialization

  • Breast medical oncology
  • HER2-positive breast cancer — early and metastatic
  • Triple-negative breast cancer (TNBC) — immunotherapy and antibody-drug conjugates
  • HR-positive/HER2-negative breast cancer — CDK4/6 inhibitors, endocrine therapy
  • HER2-low breast cancer
  • Antibody-drug conjugates (sacituzumab govitecan, trastuzumab deruxtecan, T-DM1)
  • Immune checkpoint inhibitors in breast cancer
  • De-escalation strategies in early HER2-positive disease
  • Brain metastases and leptomeningeal disease in breast cancer
  • Translational immunology and tumor microenvironment
  • Liquid biopsy and circulating tumor DNA
  • Clinical trial design and conduct — phase 1 through phase 3

Publications

Dr. Tolaney has authored and co-authored more than 1,000 publications in The New England Journal of Medicine, The Lancet, The Lancet Oncology, JAMA Oncology, Nature Medicine, Nature Reviews Clinical Oncology, Nature Reviews Cancer, Journal of Clinical Oncology, Annals of Oncology, Cancer Discovery, Clinical Cancer Research, NPJ Breast Cancer, ESMO Open, and others.

Select Publications (most cited and most recent):

Tolaney SM, de Azambuja E, Kalinsky K, Loi S, Kim SB, Yam C, et al. “Sacituzumab Govitecan plus Pembrolizumab for Advanced Triple-Negative Breast Cancer.” New England Journal of Medicine 394(4):354–366, 2026.

Tolaney SM, Jiang Z, Zhang Q, Barroso-Sousa R, Park YH, Rimawi MF, et al. “Trastuzumab deruxtecan plus pertuzumab for HER2-positive metastatic breast cancer.” New England Journal of Medicine 394(6):551–562, 2026. 54 citations.

Bardia A, Hurvitz SA, Tolaney SM, Loirat D, Punie K, Oliveira M, Brufsky A, et al. “Sacituzumab govitecan in metastatic triple-negative breast cancer.” New England Journal of Medicine 384(16):1529–1541, 2021. 1920 citations.

Johnston SRD, Harbeck N, Hegg R, Toi M, Martin M, Shao ZM, Zhang QY, Tolaney SM, et al. “Abemaciclib combined with endocrine therapy for the adjuvant treatment of HR+, HER2−, node-positive, high-risk, early breast cancer (monarchE).” Journal of Clinical Oncology 38(34):3987–3998, 2020. 1223 citations.

Rugo HS, Bardia A, Marmé F, Cortés J, Schmid P, Loirat D, Trédan O, Tolaney SM, et al. “Overall survival with sacituzumab govitecan in hormone receptor-positive and HER2-negative metastatic breast cancer (TROPiCS-02).” The Lancet 402(10411):1423–1433, 2023. 502 citations.

Tarantino P, Hamilton E, Tolaney SM, Cortes J, Morganti E, Ferraro E, et al. “HER2-low breast cancer: pathological and clinical landscape.” Journal of Clinical Oncology 38(17):1951–1962, 2020. 911 citations.

Tarantino P, Viale G, Press MF, Hu X, Penault-Llorca F, Bardia A, Tolaney SM, et al. “ESMO expert consensus statements on the definition, diagnosis, and management of HER2-low breast cancer.” Annals of Oncology 34(8):645–659, 2023. 402 citations.

Tolaney SM, Barry WT, Dang CT, Yardley DA, Moy B, Marcom PK, et al. “Adjuvant paclitaxel and trastuzumab for node-negative, HER2-positive breast cancer.” New England Journal of Medicine 372(2):134–141, 2015. 961 citations.

Tolaney SM, Tarantino P, Graham N, Tayob N, Paré L, Villacampa G, et al. “Adjuvant paclitaxel and trastuzumab for node-negative, HER2-positive breast cancer: final 10-year analysis of the open-label, single-arm, phase 2 APT trial.” The Lancet Oncology 24(3):273–285, 2023. 202 citations.

Bardia A, Mayer IA, Vahdat LT, Tolaney SM, Isakoff SJ, Diamond JR, et al. “Sacituzumab govitecan-hziy in refractory metastatic triple-negative breast cancer.” New England Journal of Medicine 380(8):741–751, 2019. 1029 citations.

Vinayak S, Tolaney SM, Schwartzberg L, Mita M, McCann G, Tan AR, et al. “Open-label clinical trial of niraparib combined with pembrolizumab for treatment of advanced or metastatic triple-negative breast cancer.” JAMA Oncology 5(8):1132–1140, 2019. 474 citations.

Tolaney SM, Wardley AM, Zambelli S, Hilton JF, Troso-Sandoval TA, et al. “Abemaciclib plus trastuzumab with or without fulvestrant versus trastuzumab plus standard-of-care chemotherapy in women with HR+, HER2+ advanced breast cancer (monarcHER).” The Lancet Oncology 21(6):763–775, 2020. 290 citations.

Tolaney SM, Kalinsky K, Kaklamani VG, D’Adamo DR, Aktan G, Tsai ML, et al. “Eribulin plus pembrolizumab in patients with metastatic triple-negative breast cancer (ENHANCE 1).” Clinical Cancer Research 27(11):3061–3068, 2021. 124 citations.

Tolaney SM, Tayob N, Dang C, Yardley DA, Isakoff SJ, Valero V, et al. “Adjuvant trastuzumab emtansine versus paclitaxel in combination with trastuzumab for stage I HER2-positive breast cancer (ATEMPT).” Journal of Clinical Oncology 39(21):2375–2385, 2021. 171 citations.

Tolaney SM, Mayer EL, Ren Y, Wagle N, Mahtani R, Ma C, DeMichele A, Cristofanilli M, et al. “PACE: a randomized phase II study of fulvestrant, palbociclib, and avelumab after progression on CDK4/6 inhibitor and aromatase inhibitor for hormone receptor-positive, HER2-negative metastatic breast cancer.” Journal of Clinical Oncology 42(17):2050–2060, 2024. 130 citations.

Tolaney SM, Sahebjam E, Le Rhun E, Bachelot T, Kabos P, Awada A, et al. “A phase II study of abemaciclib in patients with brain metastases secondary to hormone receptor-positive breast cancer.” Clinical Cancer Research 26(20):5310–5319, 2020. 244 citations.

Tarantino P, Ricciuti B, Pradhan SM, Tolaney SM. “Optimizing the safety of antibody-drug conjugates for patients with solid tumours.” Nature Reviews Clinical Oncology 20(8):558–576, 2023. 245 citations.

Spring LM, Tolaney SM, Fell G, Bossuyt V, Abelman RO, Wu B, et al. “Response-guided neoadjuvant sacituzumab govitecan for localized triple-negative breast cancer: results from the NeoSTAR trial.” Annals of Oncology 35(3):293–301, 2024. 72 citations.

Johnston S, Martin M, O’Shaughnessy J, Hegg R, Tolaney SM, Guarneri V, et al. “Overall survival with abemaciclib in early breast cancer.” Annals of Oncology, 2025. 56 citations.

Cortés J, Punie K, Barrios C, Hurvitz SA, Schneeweiss J, Sohn J, Tolaney SM, et al. “Sacituzumab govitecan in untreated, advanced triple-negative breast cancer.” New England Journal of Medicine 393(19):1912–1925, 2025. 49 citations.

All information is sourced from publicly available materials.