Sara M. Tolaney
Elite in Breast Cancer

Dr. Sara M. Tolaney

Oncology
Brigham and Women’s Hospital
Dana-Farber Cancer Institute, Breast Oncology Program
450 Brookline Avenue, Susan F. Smith Center For Women's Cancers, 
Boston, MA 
Clinical Trials:Currently Recruiting for 2 Trials
Elite in Breast Cancer
Brigham and Women’s Hospital
Dana-Farber Cancer Institute, Breast Oncology Program
450 Brookline Avenue, Susan F. Smith Center For Women's Cancers, 
Boston, MA 
OverviewInsuranceLocationsClinical ResearchSimilar Doctors

Overview

Dr. Tolaney is Chief of the Division of Breast Oncology at Dana-Farber Cancer Institute, and Associate Professor of Medicine at Harvard Medical School.  She is a breast medical oncologist whose research focuses on the development of novel therapies in the treatment of breast cancer.  She has been instrumental in developing several treatment approaches for breast cancer, including approaches focused on tailoring therapy for early stage HER2+ disease, use of cdk 4/6 inhibitors, antibody drug conjugates, and immunotherapy.She is a member of the National Cancer Institute Breast Cancer Steering Committee and is Vice Chair for Late-Stage Development in Breast Cancer in the Alliance for Clinical Trials in Oncology. Her research has been funded by the Breast Cancer Research Foundation and Susan G. Komen. She currently chairs multiple phase 3 trials in breast cancer and serves on several steering committees for practice-changing trials.  Her work has been published in journals such as the New England Journal of Medicine, Lancet, Lancet Oncology, Journal of Clinical Oncology, and others. She received her undergraduate degree from Princeton University in 1998 and her medical degree from UC San Francisco in 2002. She subsequently completed her residency in Internal Medicine at Johns Hopkins University, and fellowships in hematology and medical oncology at Dana-Farber Cancer Institute. She obtained a Masters in Public Health from the Harvard School of Public Health in 2007. In 2008, she joined the staff of Dana-Farber Cancer Institute and Brigham and Women's Hospital.

Dr. Tolaney is rated as an Elite provider by MediFind in the treatment of Breast Cancer. Her top areas of expertise are Breast Cancer, HER-2 Positive Breast Cancer, Triple-Negative Breast Cancer, and Inflammatory Breast Cancer.

Her clinical research consists of co-authoring 411 peer reviewed articles and participating in 37 clinical trials. MediFind looks at clinical research from the past 15 years. In particular, she has co-authored 361 articles and participated in 36 clinical trials in the study of Breast Cancer.

Graduate Institution
University Of California, San Francisco, School Of Medicine, 1998 - 2002
Residency
Johns Hopkins Hospital, 2002 - 2005
Specialties
Oncology
Licenses
Internal Medicine in MA
Board Certifications
Medical Oncology
Fellowships
Dana Farber Cancer Institute******, 2005 - 2008
Hospital Affiliations
Brigham And Women's Hospital
Languages Spoken
English
Gender
Female

Insurance

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Accepted insurance plans:

Aetna
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Humana
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UnitedHealthcare
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Wellcare
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Locations

Dana-Farber Cancer Institute, Breast Oncology Program
450 Brookline Avenue, Susan F. Smith Center For Women's Cancers, Boston, MA 02115
Call: 617-632-2335

Clinical Research

Clinical research consists of overseeing clinical studies of patients undergoing new treatments and therapies, and publishing articles in peer reviewed medical journals. Providers who actively participate in clinical research are generally at the forefront of the fields and aware of the most up-to-date advances in treatments for their patients.

33 Clinical Trials

Saci-IO TNBC: Randomized Phase II Study of Sacituzumab Govitecan With or Without Pembrolizumab in PD-L1-negative Metastatic Triple Negative Breast Cancer (TNBC)
Saci-IO TNBC: Randomized Phase II Study of Sacituzumab Govitecan With or Without Pembrolizumab in PD-L1-negative Metastatic Triple Negative Breast Cancer (TNBC)
Enrollment Status: Recruiting
Publish Date: December 05, 2025
Intervention Type: Drug
Study Drugs: Sacituzumab Govitecan, Pembrolizumab
Study Phase: Phase 2
An Open-label, Multi-center Rollover Protocol for Patients Who Have Participated in a Novartis-sponsored Ribociclib (LEE011) Study and Are Continuing to Benefit From Ribociclib as Single Agent or in Combination With Other Investigational Treatments
An Open-label, Multi-center Rollover Protocol for Patients Who Have Participated in a Novartis-sponsored Ribociclib (LEE011) Study and Are Continuing to Benefit From Ribociclib as Single Agent or in Combination With Other Investigational Treatments
Enrollment Status: Recruiting
Publish Date: April 26, 2024
Intervention Type: Drug
Study Phase: Phase 2
Randomized, Double-blind, Phase 3 Study of Tucatinib or Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Subjects With Unresectable Locally-advanced or Metastatic HER2+ Breast Cancer (HER2CLIMB-02)
Randomized, Double-blind, Phase 3 Study of Tucatinib or Placebo in Combination With Ado-trastuzumab Emtansine (T-DM1) for Subjects With Unresectable Locally-advanced or Metastatic HER2+ Breast Cancer (HER2CLIMB-02)
Enrollment Status: Active_not_recruiting
Publish Date: December 10, 2025
Intervention Type: Drug
Study Drugs: tucatinib, T-DM1
Study Phase: Phase 3
A Phase Ib/II Study of Olaparib With Sapacitabine in BRCA Mutant Breast Cancer
A Phase Ib/II Study of Olaparib With Sapacitabine in BRCA Mutant Breast Cancer
Enrollment Status: Active_not_recruiting
Publish Date: December 08, 2025
Intervention Type: Drug
Study Drugs: Sapacitabine, Olaparib
Study Phase: Phase 1
MONARCH 2: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Fulvestrant With or Without Abemaciclib, a CDK4/6 Inhibitor, for Women With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer
MONARCH 2: A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Fulvestrant With or Without Abemaciclib, a CDK4/6 Inhibitor, for Women With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer
Enrollment Status: Active_not_recruiting
Publish Date: October 21, 2025
Intervention Type: Drug
Study Drugs: Abemaciclib, Fulvestrant
Study Phase: Phase 3
A Pilot Study Of Changes In PD-L1 Expression During Preoperative Treatment With Nab-Paclitaxel And Pembrolizumab In Hormone Receptor-Positive Breast Cancer
A Pilot Study Of Changes In PD-L1 Expression During Preoperative Treatment With Nab-Paclitaxel And Pembrolizumab In Hormone Receptor-Positive Breast Cancer
Enrollment Status: Active_not_recruiting
Publish Date: October 08, 2025
Intervention Type: Drug, Procedure
Study Drugs: Pembrolizumab, Nab-Paclitaxel
Study Phase: Phase 1
A Phase 1b Study of Safety and Immune Response to PVX-410 Vaccine Alone and in Combination With Durvalumab in Human Leukocyte Antigen (HLA)-A2+ Subjects Following Standard Treatment of Stage II or III Triple Negative Breast Cancer
A Phase 1b Study of Safety and Immune Response to PVX-410 Vaccine Alone and in Combination With Durvalumab in Human Leukocyte Antigen (HLA)-A2+ Subjects Following Standard Treatment of Stage II or III Triple Negative Breast Cancer
Enrollment Status: Active_not_recruiting
Publish Date: October 01, 2025
Intervention Type: Drug, Biological
Study Drugs: PVX-410, Durvalumab, Hiltonol
Study Phase: Phase 1
A Phase 1b Study of Safety and Immune Response to PVX-410 Vaccine Alone and in Combination With Pembrolizumab in HLA-A2+ Patients With Metastatic Triple Negative Breast Cancer (TNBC)
A Phase 1b Study of Safety and Immune Response to PVX-410 Vaccine Alone and in Combination With Pembrolizumab in HLA-A2+ Patients With Metastatic Triple Negative Breast Cancer (TNBC)
Enrollment Status: Active_not_recruiting
Publish Date: October 01, 2025
Intervention Type: Drug, Biological
Study Drugs: Pembrolizumab, PVX-410
Study Phase: Phase 1
A Randomized Phase II Trial of Carboplatin With or Without Nivolumab in First-line Metastatic Triple-negative Breast Cancer
A Randomized Phase II Trial of Carboplatin With or Without Nivolumab in First-line Metastatic Triple-negative Breast Cancer
Enrollment Status: Active_not_recruiting
Publish Date: September 29, 2025
Intervention Type: Drug
Study Drugs: Carboplatin, Nivolumab
Study Phase: Phase 2
eMonarcHER: A Randomized, Double Blind, Placebo-Controlled Phase 3 Study of Abemaciclib Plus Standard Adjuvant Endocrine Therapy in Participants With High-Risk, Node-Positive, HR+, HER2+ Early Breast Cancer Who Have Completed Adjuvant HER2-Targeted Therapy
eMonarcHER: A Randomized, Double Blind, Placebo-Controlled Phase 3 Study of Abemaciclib Plus Standard Adjuvant Endocrine Therapy in Participants With High-Risk, Node-Positive, HR+, HER2+ Early Breast Cancer Who Have Completed Adjuvant HER2-Targeted Therapy
Enrollment Status: Terminated
Publish Date: July 15, 2025
Intervention Type: Drug
Study Drugs: Abemaciclib, Standard Adjuvant Endocrine Therapy
Study Phase: Phase 3
Saci-IO HR+: Randomized Phase II Study of Sacituzumab Govitecan With or Without Pembrolizumab in Hormone Receptor-positive (HR+) / HER2- Metastatic Breast Cancer (MBC)
Saci-IO HR+: Randomized Phase II Study of Sacituzumab Govitecan With or Without Pembrolizumab in Hormone Receptor-positive (HR+) / HER2- Metastatic Breast Cancer (MBC)
Enrollment Status: Active_not_recruiting
Publish Date: June 25, 2025
Intervention Type: Drug
Study Drugs: Pembrolizumab, Sacituzumab Govitecan
Study Phase: Phase 2
A Phase 2 Study of Abemaciclib for Patients With Retinoblastoma-Positive, Triple Negative Metastatic Breast Cancer
A Phase 2 Study of Abemaciclib for Patients With Retinoblastoma-Positive, Triple Negative Metastatic Breast Cancer
Enrollment Status: Terminated
Publish Date: June 24, 2025
Intervention Type: Drug
Study Drug: Abemaciclib
Study Phase: Phase 2
A Phase II Trial of Cabozantinib in Women With Metastatic Hormone-Receptor-Positive Breast Cancer With Involvement of Bone
A Phase II Trial of Cabozantinib in Women With Metastatic Hormone-Receptor-Positive Breast Cancer With Involvement of Bone
Enrollment Status: Completed
Publish Date: May 25, 2025
Intervention Type: Drug
Study Drugs: Cabozantinib, Fulvestrant
Study Phase: Phase 2
A Randomized, Open-Label, Phase 3 Study of Abemaciclib Combined With Standard Adjuvant Endocrine Therapy Versus Standard Adjuvant Endocrine Therapy Alone in Patients With High Risk, Node Positive, Early Stage, Hormone Receptor Positive, Human Epidermal Receptor 2 Negative, Breast Cancer
A Randomized, Open-Label, Phase 3 Study of Abemaciclib Combined With Standard Adjuvant Endocrine Therapy Versus Standard Adjuvant Endocrine Therapy Alone in Patients With High Risk, Node Positive, Early Stage, Hormone Receptor Positive, Human Epidermal Receptor 2 Negative, Breast Cancer
Enrollment Status: Active_not_recruiting
Publish Date: April 20, 2025
Intervention Type: Drug
Study Drugs: Abemaciclib, Standard Adjuvant Endocrine Therapy
Study Phase: Phase 3
A Phase 1b Study of Abemaciclib in Combination With Therapies for Patients With Metastatic Breast Cancer
A Phase 1b Study of Abemaciclib in Combination With Therapies for Patients With Metastatic Breast Cancer
Enrollment Status: Active_not_recruiting
Publish Date: April 20, 2025
Intervention Type: Drug
Study Drugs: LY2835219, Letrozole, Anastrozole, Tamoxifen, Exemestane, Everolimus, Trastuzumab, LY3023414, Fulvestrant, Pertuzumab, Loperamide, Endocrine therapy
Study Phase: Phase 1
A Phase 1b Study of Abemaciclib in Combination With Pembrolizumab for Patients With Stage IV Non-Small Cell Lung Cancer or Hormone Receptor Positive, HER2 Negative Breast Cancer
A Phase 1b Study of Abemaciclib in Combination With Pembrolizumab for Patients With Stage IV Non-Small Cell Lung Cancer or Hormone Receptor Positive, HER2 Negative Breast Cancer
Enrollment Status: Active_not_recruiting
Publish Date: April 18, 2025
Intervention Type: Drug
Study Drugs: Abemaciclib, Pembrolizumab, Anastrozole
Study Phase: Phase 1
A Phase I Dose-Escalation Study of Oral ABT-888 (NSC #737664) Plus Intravenous Irinotecan (CPT-11, NSC#616348) Administered in Patients With Advanced Solid Tumors
A Phase I Dose-Escalation Study of Oral ABT-888 (NSC #737664) Plus Intravenous Irinotecan (CPT-11, NSC#616348) Administered in Patients With Advanced Solid Tumors
Enrollment Status: Completed
Publish Date: April 15, 2025
Intervention Type: Other, Drug
Study Drugs: Irinotecan Hydrochloride, Veliparib
Study Phase: Phase 1
A Randomized Phase II Study of Trastuzumab Emtansine (T-DM1) vs. Paclitaxel in Combination With Trastuzumab for Stage I HER2-Positive Breast Cancer (ATEMPT Trial)
A Randomized Phase II Study of Trastuzumab Emtansine (T-DM1) vs. Paclitaxel in Combination With Trastuzumab for Stage I HER2-Positive Breast Cancer (ATEMPT Trial)
Enrollment Status: Active_not_recruiting
Publish Date: March 17, 2025
Intervention Type: Drug
Study Drugs: Trastuzumab, Paclitaxel, Trastuzumab emtansine
Study Phase: Phase 2
NIMBUS: A Phase II Study of Nivolumab Plus Ipilimumab in Metastatic Hypermutated HER2-negative Breast Cancer
NIMBUS: A Phase II Study of Nivolumab Plus Ipilimumab in Metastatic Hypermutated HER2-negative Breast Cancer
Enrollment Status: Active_not_recruiting
Publish Date: February 26, 2025
Intervention Type: Drug
Study Drugs: Nivolumab, Ipilimumab
Study Phase: Phase 2
Prospective Study of the Prosigna Assay on Neoadjuvant Clinical Decision-making in Women With HR+/Her2- Breast Cancer
Prospective Study of the Prosigna Assay on Neoadjuvant Clinical Decision-making in Women With HR+/Her2- Breast Cancer
Enrollment Status: Active_not_recruiting
Publish Date: February 13, 2025
Intervention Type: Other
A Phase 1b Study Of Pembrolizumab In Combination With Trastuzumab-DM1 In Metastatic HER2-Positive Breast Cancer
A Phase 1b Study Of Pembrolizumab In Combination With Trastuzumab-DM1 In Metastatic HER2-Positive Breast Cancer
Enrollment Status: Completed
Publish Date: January 27, 2025
Intervention Type: Drug
Study Drugs: T-DM1, Pembrolizumab
Study Phase: Phase 1
monarcHER: A Phase 2, Randomized, Multicenter, 3-Arm, Open-Label Study to Compare the Efficacy of Abemaciclib Plus Trastuzumab With or Without Fulvestrant to Standard-of-Care Chemotherapy of Physician's Choice Plus Trastuzumab in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer
monarcHER: A Phase 2, Randomized, Multicenter, 3-Arm, Open-Label Study to Compare the Efficacy of Abemaciclib Plus Trastuzumab With or Without Fulvestrant to Standard-of-Care Chemotherapy of Physician's Choice Plus Trastuzumab in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer
Enrollment Status: Completed
Publish Date: November 26, 2024
Intervention Type: Drug
Study Drugs: Abemaciclib, Trastuzumab, Fulvestrant, Standard of Care Single Agent Chemotherapy
Study Phase: Phase 2
A Randomized Phase II Study Of Eribulin Mesylate With Or Without Pembrolizumab For Metastatic Hormone Receptor Positive Breast Cancer
A Randomized Phase II Study Of Eribulin Mesylate With Or Without Pembrolizumab For Metastatic Hormone Receptor Positive Breast Cancer
Enrollment Status: Completed
Publish Date: March 06, 2024
Intervention Type: Drug
Study Drugs: Eribulin Mesylate, Pembrolizumab
Study Phase: Phase 2
Double Blind, Parallel Groups, Controlled, Randomized Phase II Trial to Evaluate Vaccination With Folate Receptor Alpha Peptide Vaccine With GM-CSF as Vaccine Adjuvant Following Oral Cyclophosphamide Versus GM-CSF/Placebo to Prevent Recurrence in Patients With Triple Negative Breast Cancer
Double Blind, Parallel Groups, Controlled, Randomized Phase II Trial to Evaluate Vaccination With Folate Receptor Alpha Peptide Vaccine With GM-CSF as Vaccine Adjuvant Following Oral Cyclophosphamide Versus GM-CSF/Placebo to Prevent Recurrence in Patients With Triple Negative Breast Cancer
Enrollment Status: Active_not_recruiting
Publish Date: January 13, 2023
Intervention Type: Drug, Other, Biological
Study Drugs: Cyclophosphamide, Multi-epitope Folate Receptor Alpha Peptide Vaccine, Sargramostim
Study Phase: Phase 2
A Phase 1b/2a Study Of Palbociclib In Combination With Everolimus And Exemestane In Postmenopausal Women With Estrogen Receptor Positive and HER2 Negative Metastatic Breast Cancer
A Phase 1b/2a Study Of Palbociclib In Combination With Everolimus And Exemestane In Postmenopausal Women With Estrogen Receptor Positive and HER2 Negative Metastatic Breast Cancer
Enrollment Status: Completed
Publish Date: August 29, 2022
Intervention Type: Drug
Study Drugs: Palbociclib, Everolimus, Exemestane
Study Phase: Phase 1/Phase 2
An Open-Label, Phase Ib/II Clinical Trial Of Cdk 4/6 Inhibitor, Ribociclib (Lee011), In Combination With Trastuzumab Or T-Dm1 For Advanced/Metastatic Her2-Positive Breast Cancer.
An Open-Label, Phase Ib/II Clinical Trial Of Cdk 4/6 Inhibitor, Ribociclib (Lee011), In Combination With Trastuzumab Or T-Dm1 For Advanced/Metastatic Her2-Positive Breast Cancer.
Enrollment Status: Completed
Publish Date: August 01, 2022
Intervention Type: Drug
Study Drugs: Ribociclib, T-DM1, Trastuzumab, Fulvestrant
Study Phase: Phase 1/Phase 2
A Phase II Study of Nivolumab in Combination With Cabozantinib for Metastatic Triple-negative Breast Cancer
A Phase II Study of Nivolumab in Combination With Cabozantinib for Metastatic Triple-negative Breast Cancer
Enrollment Status: Completed
Publish Date: December 28, 2021
Intervention Type: Drug
Study Drugs: Nivolumab, Cabozantinib
Study Phase: Phase 2
A Phase II Study of Cisplatin + AZD1775 in Metastatic Triple-negative Breast Cancer and Evaluation of pCDC2 as a Biomarker of Target Response
A Phase II Study of Cisplatin + AZD1775 in Metastatic Triple-negative Breast Cancer and Evaluation of pCDC2 as a Biomarker of Target Response
Enrollment Status: Completed
Publish Date: November 23, 2021
Intervention Type: Drug
Study Drugs: Cisplatin, AZD1775
Study Phase: Phase 2
A Multinational, Multicenter, Randomized, Phase 3 Study of Tesetaxel Plus a Reduced Dose of Capecitabine Versus Capecitabine Alone in Patients With HER2 Negative, HR Positive, Locally Advanced or Metastatic Breast Cancer Previously Treated With a Taxane
A Multinational, Multicenter, Randomized, Phase 3 Study of Tesetaxel Plus a Reduced Dose of Capecitabine Versus Capecitabine Alone in Patients With HER2 Negative, HR Positive, Locally Advanced or Metastatic Breast Cancer Previously Treated With a Taxane
Enrollment Status: Terminated
Publish Date: July 30, 2021
Intervention Type: Drug
Study Drugs: Tesetaxel and Capecitabine, Capecitabine
Study Phase: Phase 3
A Phase II Study of Cabozantinib Alone or in Combination With Trastuzumab in Breast Cancer Patients With Brain Metastases
A Phase II Study of Cabozantinib Alone or in Combination With Trastuzumab in Breast Cancer Patients With Brain Metastases
Enrollment Status: Completed
Publish Date: May 20, 2021
Intervention Type: Drug
Study Drugs: Cabozantinib, Trastuzumab
Study Phase: Phase 2
A Phase II Study Of Pembrolizumab In Combination With Palliative Radiotherapy For Metastatic Hormone Receptor Positive Breast Cancer
A Phase II Study Of Pembrolizumab In Combination With Palliative Radiotherapy For Metastatic Hormone Receptor Positive Breast Cancer
Enrollment Status: Terminated
Publish Date: April 27, 2021
Intervention Type: Drug, Radiation
Study Phase: Phase 2
A Phase 2 Study of Abemaciclib in Patients With Brain Metastases Secondary to Hormone Receptor Positive Breast Cancer, Non-small Cell Lung Cancer, or Melanoma
A Phase 2 Study of Abemaciclib in Patients With Brain Metastases Secondary to Hormone Receptor Positive Breast Cancer, Non-small Cell Lung Cancer, or Melanoma
Enrollment Status: Completed
Publish Date: December 19, 2020
Intervention Type: Drug
Study Phase: Phase 2
A Phase 1b Study of Aurora A Kinase Inhibitor LY3295668 Erbumine in Monotherapy and Combination Therapy in Patients With Metastatic Breast Cancer Post CDK4/6 Inhibitor and Endocrine Therapy
A Phase 1b Study of Aurora A Kinase Inhibitor LY3295668 Erbumine in Monotherapy and Combination Therapy in Patients With Metastatic Breast Cancer Post CDK4/6 Inhibitor and Endocrine Therapy
Enrollment Status: Completed
Publish Date: June 01, 2020
Intervention Type: Drug
Study Phase: Phase 1
View 31 Less Clinical Trials

411 Total Publications

Erratum: Decoding Clinical Trials in Metastatic Breast Cancer: Practical Insights for Optimal Therapy Sequencing.
Erratum: Decoding Clinical Trials in Metastatic Breast Cancer: Practical Insights for Optimal Therapy Sequencing.
Journal: American Society of Clinical Oncology educational book. American Society of Clinical Oncology. Annual Meeting
Published: November 21, 2025
View All 411 Publications
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  • Breast Cancer
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  • Febrile Neutropenia
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  • Anemia
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  • Ataxia-Telangiectasia
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