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Angelo Di Leo, MD, PhD

Head of Sandro Pitigliani Medical Oncology Unit
Department of Oncology Hospital of Prato
Istituto Toscani Tumori
Prato, Italy

Current Research

  • Seeking better treatment strategies for patients with ER-positive and HER2-positive breast cancers.

  • A clinical trial is conducted to identify patients who could safely replace chemotherapy with a new class of drugs called CDK4/6 inhibitors.

  • These studies will lead to a more personalized approach to improve outcomes for patients with ER-positive of HER2 positive breast cancer.

Dr. Di Leo and colleagues are studying breast cancers that express estrogen receptors (ER) and HER2, referred to as ER-positive and HER2-positive, respectively. These breast cancers are treated with targeted therapies usually in combination with chemotherapy.

This year, Dr. Di Leo’s team will work to identify which patients could safely avoid chemotherapy, and instead receive a CDK4/6 inhibitor with their targeted therapy. CDK4/6 inhibitors are a new class of targeted drugs that have been FDA-approved for patients with advanced ER-positive breast cancer. Dr. Di Leo will use a tumor gene signature called “RBsig" to predict response to CDK4/6 inhibitors. Cancers with low levels of RBsig are less likely to respond to chemotherapy, and may respond better to anti-CDK4/6 therapy.

In an initial clinical trial, women with early stage ER-positive or HER2-positive breast cancer will receive treatment prior to surgery (called neoadjuvant therapy). RBsig status of the tumor will be measured prior to starting treatment. Patients will receive either standard therapy (targeted therapy plus chemotherapy) or targeted therapy plus a CDK4/6 inhibitor. After completing neoadjuvant therapy, all women will undergo surgery, and the research team will measure how much the tumor shrank in response to the neoadjuvant therapy.

The researchers expect that tumors with high RBsig expression will shrink the most if they receive the chemotherapy regimen, and those with low RBsig will shrink the most if they receive the CDK4/6 inhibitor instead of chemotherapy. If this is what they find, RBsig could be used in the future to determine which treatment combination is best. The results from these studies could further improve personalized medicine.


Angelo Di Leo is Head of the Sandro Pitigliani Medical Oncology Department at the Hospital of Prato, Istituto Toscano Tumori, Italy, since September 2003. He trained at the National Cancer Institute in Milan, where he worked for seven years. From 1996 to 2003, he was with the Chemotherapy Unit of the Jules Bordet Institute in Brussels, and was appointed senior staff member in 1997.

His main research interest is breast cancer and he has coordinated a number of international, pivotal Phase III trials in new adjuvant therapies. He is also involved in the evaluation of molecular markers with potential predictive value to treat breast cancer patients. He is a member of the Early Breast Cancer Trialists’ Cooperative Group steering committee and the Scientific Advisory Council of the Susan G. Komen for the Cure®, and was a former member of the ASCO grants selection (2006–2009) and educational (2012-2014) committee. He serves as member of the Breast International Group Executive Board.

BCRF Investigator Since


Area(s) of Focus

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