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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

Goal: To discover better strategies for treating patients with estrogen receptor (ER)-positive and HER2-positive breast cancers.

Impact: Dr. Di Leo has identified a marker that could help determine which patients will benefit from targeted, less toxic therapies for breast cancer. This would be of particular benefit to the elderly, who may be frail and have other medical conditions that make breast cancer treatment more challenging.

What’s next: To test whether this marker could predict patient outcomes, Dr. Di Leo and his team have launched an international trial that will compare two treatment regimens—one that includes chemotherapy and one that doesn’t—in elderly patients with ER-positive and HER2-positive breast cancer.

Chemotherapy is believed to reduce the risk of breast cancer recurrence and is a standard part of therapy for most people who have the disease. Even when targeted therapy such as tamoxifen and Herceptin® can be used for certain types of the breast cancer, chemotherapy may be still be included in the treatment plan. Dr. Di Leo has identified and is testing a marker that may help determine which patients could forgo chemotherapy in favor of more tolerable treatments.

Full Research Summary

Research area: Identifying patients with ER-positive or HER2-positive breast cancer who may respond to treatments that are less toxic and better tolerated than chemotherapy—a standard component of most breast cancer therapies.

Impact: While targeted treatments exist for certain types of breast cancer, they are usually used in combination with chemotherapy to reduce the risk that the cancer will come back, which is a concern even in early stage disease. Through preclinical and prospective studies, Dr. Di Leo is exploring biomarkers that could identify which patients can avoid chemotherapy.

Current investigation: He and his team are focusing their work on the elderly, a group of patients who often suffer from age-related frailty and other co-morbidities. They are conducting a clinical trial that will compare two different early breast cancer treatment regimens given prior to curative surgery (called neoadjuvant therapy) in elderly patients.

What he’s learned so far: Dr. Di Leo’s prior work suggests that patients whose cancer expresses low levels of the gene signature “RBsig” are less likely to respond to chemotherapy, and may benefit more from targeted, potentially less toxic therapies such as CDK4/6 inhibitors.

What’s next: With the support of BCRF, Dr. Di Leo and his team will test the correlation between RBsig and clinical outcome in a prospective multi-center, international trial. Elderly women with hormone receptor positive, HER2-positive early breast cancer will be randomized to receive standard neoadjuvant chemotherapy plus anti-HER2 treatment or a CDK4/6 inhibitor, letrozole (hormonal therapy), and anti-HER2 treatment.


Angelo Di Leo is currently Head of the Sandro Pitigliani Medical Oncology Department at the Hospital of Prato, Italy, a position he took up in September 2003. After graduating in medicine and surgery at the University of Palermo, Italy in 1988, he received his postgraduate diploma in medical oncology from the University of Pavia, Italy in 1992, and in 1996 received his European certification in medical oncology.

Dr Di Leo trained at the National Cancer Institute in Milan, Italy, where he worked for 7 years until 1996. From 1996 to 2003, he worked at the Chemotherapy Unit of the Jules Bordet Institute in Brussels, Belgium, where in 1997 he was appointed senior staff member and medical director of the Breast European Adjuvant Studies Team.

Dr Di Leo’s 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 heavily involved in the evaluation of molecular markers with potential predictive value for breast cancer. The author of many peer-reviewed articles, Dr Di Leo has lectured extensively at national and international meetings. He is a member of the Early Breast Cancer Trialists’ Cooperative Group steering committee, the Breast International Group Executive Board, co-chair of the International Breast Cancer Study Group – IBCSG, and chair of the Biological Protocol Working Group (BPWG) - IBCSG. He has also served on the American Society of Clinical Oncology (ASCO) grants selection committee (2006–2009), the ASCO Education Committee (2012–2014), and the Scientific Advisory Council of the Susan G. Komen for the Cure® (2010-2016). In 2019, Dr Di Leo’s outstanding contributions to the field of breast cancer was recognised by the European Society of Medical Oncology (ESMO), awarding him the prestigious ESMO Lifetime Achievement Award.

BCRF Investigator Since


Donor Recognition

The Estée Lauder Companies' Award in Honor of Fabrizio Freda

Area(s) of Focus