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Monica Bertagnolli, MD

Chief, Division of Surgical Oncology
Dana-Farber Cancer Institute/Harvard Medical School
Brigham and Women's Hospital
President, Alliance for Clinical Trials in Oncology
Boston, Massachusetts

Current Research

Goal: To discover biomarkers that can help identify breast cancer patients who are most likely to respond to therapy or who are at risk for experiencing side effects.

Impact: Dr. Bertagnolli is analyzing clinical trial data to identify markers of response that will help guide the use of chemotherapy, targeted drugs, and/or hormonal therapy prior surgery. Her work could lead to improvements in patient outcomes.

What’s next: She and her team will continue their analyses of patient data. They will also look for genetic markers that might predict for an increased risk of lymphedema (a burdensome concern for breast cancer survivors) or guide treatment decisions in patients with advanced breast cancer.

Tissue and blood samples collected from patients in clinical trials are a valuable resource for identifying predictive markers of response to breast cancer treatment and the likelihood of toxicity. Dr. Bergatnolli is analyzing samples from large groups of patients enrolled in clinical trials to determine which specific tumor characteristics predict a better response. She and her team are also attempting to identify which patients may be at risk for developing therapy-induced lymphedema.

Full Research Summary

Research area: Identifying predictive biomarkers of response to treatment (or lack thereof) and toxicity in early stage and metastatic breast cancers.

Impact: Patient outcomes could be improved if doctors knew how to predict response and which patients are more likely to benefit from a specific therapy. In addition, a patient’s quality of life might be better if doctors could predict which patients are at risk for side effects like lymphedema, which affects many breast cancer survivors. Dr. Bertagnolli aims to identify markers that may help doctors and patients make treatment decisions based on what is most important to the patient. If successful, her work could lead to major advances in personalized therapy.

Current investigation: As Group Chair of the National Cancer Institute-designated Alliance for Clinical Trials in Oncology, Dr. Bertagnolli is studying blood and tissue samples from three Alliance clinical trials to identify potential biomarkers of treatment response and risk of lymphedema.

What they’ve learned so far: BCRF support of correlative studies within the Alliance clinical trial framework has been crucial to expanding the impact of the trials to advance precision medicine. Ongoing efforts are supporting pathology review of over 1000 patient reports to assess accuracy of reporting of residual cancer burden – an important post-treatment prognostic marker. 

What’s next: In addition to continuing their current work, the team will investigate two potential biomarkers that could help determine which chemotherapy agent is best for individual patients with metastatic breast cancer. They are particularly interested in how the presence and amount of tumor infiltrating immune cells and other molecular “signatures” may be used as prognostic indicators.


Dr. Bertagnolli is a Professor of Surgery at Harvard University Medical School, and an Associate Surgeon at Dana Farber Cancer Institute and Brigham and Women’s Hospital . She is presently the Chief of the Division of Surgical Oncology at Dana Farber/Brigham and Women’s Cancer Center. She is also a member of the Gastrointestinal Cancer and Sarcoma Disease Centers at DF/BWCC, where she collaborates with colleagues in medical oncology, radiation oncology, and pathology to treat cancer patients in a tertiary care setting.

Dr. Bertagnolli maintains an active research laboratory focused on understanding the role of the inflammatory response in epithelial tumor formation. In 1999, she extended her basic laboratory observations to the clinical trials setting as the lead Principal Investigator of the Adenoma Prevention with Celecoxib Trial. This pivotal study, reported in 2006, demonstrated dramatic suppression of colorectal adenomas with selective cyclooxygenase-2 inhibition, but also uncovered unanticipated cardiovascular toxicity with these agents. Dr. Bertagnolli was an organizing member of gastrointestinal correlative science initiatives within the NCI-funded Cancer Cooperative Groups, where she facilitated integration of tumor-specific molecular markers of treatment outcome into nation-wide clinical cancer treatment protocols. She has had numerous leadership roles in multi-institutional cancer clinical research consortia, and from 2010-2011 served as Group Chair of Cancer and Leukemia Group B (CALGB). Dr. Bertagnolli was elected in July 2011 to lead the Alliance for Clinical Trials in Oncology, a new NCI-funded cooperative group formed by merger of CALGB, the North Central Cancer Treatment Group, and the American College of Surgeons Oncology Group.

Grid Reasercher Headshot - Bertagnollli Monica

BCRF Investigator Since


Donor Recognition

The Ann Taylor and Loft Award (a subsidiary of ascena retail group inc.)

Area(s) of Focus