Sara Tolaney Honored With AACR’s Outstanding Investigator Award for Breast Cancer Research

Dr. Sara M. Tolaney is the recipient of the 2025 AACR Outstanding Investigator Award for Breast Cancer Research, supported by the Breast Cancer Research Foundation. This award was established to honor an investigator whose novel and significant work has had or may have a far-reaching impact on the etiology, detection, diagnosis, treatment, or prevention of breast cancer. Such work may involve any discipline across the continuum of biomedical research, including basic, translational, clinical, and epidemiological studies. Tolaney’s award lecture will be presented on Friday, December 12, at 1:30 p.m. CT at the San Antonio Breast Cancer Symposium.

Tolaney is Chief of the Division of Breast Oncology at Dana-Farber Cancer Institute and Associate Professor of Medicine at Harvard Medical School.

Tolaney is being recognized for pioneering work dedicated to optimizing targeted therapies for HER2-positive breast cancer through innovative clinical trials. Specifically, Tolaney’s APT trial demonstrated the efficacy of a less intensive regimen involving paclitaxel and trastuzumab (TH) for early-stage, node-negative disease, effectively transforming national and international clinical treatment guidelines. She also led the ATEMPT trial that demonstrated that trastuzumab emtansine (T-DM1) may represent a reasonable alternative to TH for stage 1 HER2-positive breast cancer.

Her leadership in establishing biomarker-driven personalized therapy approaches for cancer, including the development of CDK4/6 inhibitors, has significantly advanced care in both metastatic and adjuvant settings, shaping the future of precision oncology for patients with breast cancer.

In the past year, Tolaney led two groundbreaking studies that will likely change clinical practice for patients with metastatic breast cancer. An interim analysis from the DESTINY-Breast09 study—led by Tolaney, presented at the 2025 ASCO Annual Meeting, and published in the New England Journal of Medicine—showed that the combination of trastuzumab deruxtecan (T-DXd) plus pertuzumab, nearly doubled progression-free survival compared to the currently accepted standard treatment for first-line therapy of metastatic HER2-positive breast cancer. This was the first study showing a statistically significant and clinically meaningful improvement in progression free survival in this patient population since the CLEOPATRA trial established the current standard of care over a decade ago.

The ASCENT-04 study, also presented by Tolaney at ASCO, showed that the antibody-drug conjugate sacituzumab govitecan plus pembrolizumab resulted in durable responses with improved progression free survival compared to the current standard treatment in patients receiving their first treatment for advanced or metastatic triple negative breast cancer that tests positive for the immune checkpoint PD-L1. Tolaney was the senior author of the complementary ASCENT-03 study, presented at the European Society for Medical Oncology (ESMO) Congress 2025, that evaluated the use of sacituzumab govitecan versus standard chemotherapy as a first-line treatment in patients with locally advanced or unresectable TNBC who are not candidates for immune checkpoint inhibitors. The findings, also published in the New England Journal of Medicine, support sacituzumab govitecan as a potential new standard of care for this patient population.

Tolaney’s work also contributed to the approval Sacituzumab govitecan, in February 2023, for the treatment of metastatic HR+, HER2- breast cancer. The approval was based on the results of TROPICS-02 study.