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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

  • Seeking biomarkers to identify patients most likely to respond to therapy or who are at risk for experiencing side effects.
  • Analyses of clinical trial data is conducted to identify biomarkers of response and toxicity in early stage and metastatic breast cancers.
  • These studies are aimed at reducing toxicity with personalized therapy approaches.

Tissue and blood collected as part of clinical trials provide a valuable resource to identify predictive markers of response to treatment or likelihood of toxicity. BCRF has provided support for the collection of this tissue in national cancer clinical trials so that clinical trial investigators can conduct these studies. Dr. Bertagnolli is using samples from three clinical trials to identify markers that can predict who is likely to benefit from a particular therapy and who may be at risk for developing therapy-induced lymphedema. 

Full Research Summary

BCRF has provided critical support for the molecular analysis of tumor specimens from clinical trials. These efforts are fundamental to the development of biomarkers that can predict risk of recurrence, response to treatment, as well as the identification of new treatment for drug-resistant tumors. 

In early stage disease, agents may be delivered as first line treatment, followed by surgery. Giving systemic treatment (chemotherapy, targeted drugs, and/or hormonal therapy) before surgery, also known as neoadjuvant therapy, allows researchers to study the tumor’s response to therapy, and what specific tumor characteristics predict a better response and which patients may benefit from a different approach because of a lack of response. 

As Group Chair of the National Cancer Institute-designated Alliance for Clinical Trials in Oncology, Dr. Bargonetti will lead efforts to study emerging biomarkers of response to and benefits from—or lack thereof—treatment using tissue samples from patients enrolled on three Alliance trials. The identification of predictive biomarkers will help guide the use of neoadjuvant chemotherapy in early stage disease. 

In addition to identifying biomarkers of response, the researchers will also look for genetic predictors for an increased risk of lymphedema, a burdensome concern for many breast cancer survivors. 

Separately, the team will also study predictive factors in hormone receptor-positive, metastatic disease to help guide therapeutic decisions in patients with advanced breast cancer. These studies will help identify which patients will benefit from which treatments and optimize treatment decision-making for patients to enhance not only quantity, but quality of life. The goal is to safely avoid toxicities from chemotherapy for most patients with metastatic breast cancer, while more rationally selecting patients who are likely to benefit from a more aggressive approach.


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 INC. Award (a division of ascena retail group inc.)