Northwestern University Feinberg School of Medicine

Massimo Cristofanilli, MD

Professor, Medicine, Hematology Oncology Division; Feinberg School of Medicine

Massimo Cristofanilli, MD

Research Program


massimo.cristofanilli( at )

Selected Publications

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Cancer-Focused Research

I am a physician scientist known for contributions in several area of clinical and translational research including: a)The detection of and molecular characterization of micrometastatic disease; b) The research and treatment of inflammatory breast cancer (IBC), the most aggressive and deadly form of breast cancer; c) Drug development with particular focus on molecularly targeted therapies. I was among the first to demonstrate the prognostic and predictive value of circulating tumor cells (CTCs) enumeration in solid tumors, suggesting the importance of the ?liquid phase? of solid tumors. Several studies have validated the initial observation further demonstrating the prognostic value of CTCs irrespective of disease subtype, site of recurrence and type of therapy. My research has expanded to the molecular evaluation of those cells and, more recently targeted therapeutic approach using denosumab, chemokine-receptors inhibitors and immunotherapies. Furthermore, I have developed collaboration and experience in the use of circulating tumor DNA (ctDNA) developing clinical trials and algorithms to incorporate those blood-based methods in the routine evaluation of patients with advanced disease. I have worked for many years in defining the unique biological and clinical aspects of IBC. I started the first research program and clinic solely dedicated to this disease. We have advanced the knowledge about IBC identifying several molecular drivers including ALK overexpression, MYC and FAK amplification and developed dedicated clinical trials to improve the outcome of these patients. My contribution to drug development has followed a clear path of innovation, particularly in the area of endocrine resistance in hormone-receptor positive (HR+) breast cancer. Among the various mechanisms identified, this study explored the bidirectional cross-talk between ER and receptor tyrosine kinase signaling. As evidenced by the early observations, there seems to be a reciprocal expression of ER and members of the EGFR (HER) family such as EGFR and HER-2. I conducted a prospective, multicenter Phase II, randomized trial to compare anastrozole combined with gefitinib (Iressa®) or placebo in postmenopausal women with hormone receptor-positive metastatic breast cancer. The study enrolled demonstrated the superiority in PFS of the combined therapy particularly in women never previously exposed to any endocrine therapy (21). Most recently I provided leadership in the design and conduction of the Phase 3 randomized study evaluating palbociclib in combination with Fulvestrant in patients with metastatic estrogen-receptor positive disease (PALOMA-3).

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