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BCRF Grantee Since


Area(s) of Focus

Roisin M. Connolly, MB, BCh

Assistant Professor of Oncology
Sidney Kimmel Comprehensive Cancer Center
Johns Hopkins University School of Medicine
Baltimore, Maryland

Current Research

Patients with human epidermal growth factor receptor 2‐positive (HER2+) breast cancer are generally treated with trastuzumab (Herceptin®) in combination or in sequence with chemotherapy. Recent data, however, suggest that some patients derive benefit from anti‐HER2 agents alone and may not require chemotherapy. Studies also indicate that using two anti‐HER2 agents together is more effective than one agent alone. Complete tumor eradication from the breast at time of surgery (pathological complete response) was observed in 27% of patients with stage 2/3 breast cancer treated with pertuzumab (Perjeta®) and trastuzumab without chemotherapy. These results suggest that some patients can be treated with anti‐HER2 agents alone and have caused great excitement in the breast cancer community. Dr. Connolly has proposed a study, to be conducted through the Translational Breast Cancer Research Consortium (TBCRC), in which she will try to identify early markers that will help select patients who may be treated with biologic therapy alone and spared chemotherapy.

This multicenter phase 2 study will enroll patients with early stage breast cancer that is HER2+ and estrogen receptor‐negative. The results of this study will be used to design a future definitive randomized trial such that oncologists can identify those patients who do or not need chemotherapy, which has the potential to revolutionize the management of HER2+ early breast cancer. While the majority of breast cancer clinical trials add new agents to standard treatment, often with added toxicity and cost, Dr. Connolly aims to provide a personalized approach for this population of patients which will minimize treatment administered, without compromising efficacy.

Mid-Year Summary

Institutional Review Board approval was obtained for this study in June 2013. A Study Contract was signed with Genentech in December 2013. At the time of her report, Dr. Connolly anticipated opening the study to accrual in January 2014. This is a Translational Breast Cancer Research Consortium study and will enroll patients from approximately 15 sites nationwide. The results from the study will be used to design a future definitive randomized trial such that researchers can identify those patients who do or not need chemotherapy, revolutionizing the management of HER2-positive early breast cancer.


Dr. Connolly is an Assistant Professor of Oncology at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. Her principal research activities consist of designing and conducting clinical trials that test investigational new drugs in the treatment of breast cancer. Dr. Connolly’s current focus relates to the investigation of novel agents in both the neoadjuvant and metastatic settings. She is interested in developing both tissue and imaging‐based biomarkers of response to breast cancer therapies. In addition, she has specific expertise in the use of epigenetic modifiers in breast cancer patients. As a clinical investigator with a focus on translational drug development, her goal is to improve outcomes for patients with breast cancer in a research environment.