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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 to 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 response 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. Bertagnolli is analyzing samples from large groups of patients enrolled in clinical trials to determine which specific tumor characteristics predict a better response. 

Full Research Summary

Research area: Identifying predictive biomarkers of response to treatment and toxicity in early stage and metastatic breast cancers.

Impact: Large randomized controlled trials, such as Alliance/CALGB 40502, provide a unique opportunity to study a very large group of patients. The results of this trial indicated that specific tumor characteristics such as breast cancer intrinsic subtype, residual cancer burden, tumor-infiltrating lymphocytes, and genomic expression profile, may predict patient response to treatment. 

Current investigation: Dr. Bertagnolli is analyzing tissue samples from patients enrolled in the Alliance/CALGB 40502 trial in order to determine the predictive value of these factors in hormone receptor positive metastatic disease and to help guide therapeutic decisions in this population. 

What she’s 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 include the review of over 1000 patient tumor pathology reports to assess accuracy of reporting of residual cancer burden – a commonly used 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

Area(s) of Focus