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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 develop strategies to decrease the use of chemotherapy for patients with estrogen receptor-positive/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 older patients, 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 to compare two treatment regimens—one that includes chemotherapy and one that does not—in older patients with estrogen receptor-positive/HER2-positive breast cancer. His team continues to enroll patients in this clinical trial.

Chemotherapy is believed to reduce the risk of breast cancer recurrence and is a standard part of therapy for most patients. Even when targeted therapy such as tamoxifen and Herceptin® can be used for certain types of 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 estrogen receptor (ER)-positive/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 of cancer recurrence. Dr. Di Leo has identified a biomarker that can identify patients who may benefit from less toxic therapies such as CDK4/6 inhibitors. This would be of particular benefit to older patients, who may be frail and have other medical conditions that make breast cancer treatment more challenging. He has initiated an international, multi-center clinical trial to test the use of these biomarkers in determining prognosis and response to treatment in these vulnerable patients. 

Current investigation: Dr. Di Leo and his colleagues are conducting a clinical trial to compare two different early breast cancer treatment regimens given prior to curative surgery in older patients.

What he’s learned so far: Dr. Di Leo has shown that a gene signature, called RBsig, that reflects a loss of function of the retinoblastoma tumor suppressor gene are less likely to respond to chemotherapy, and may benefit more from targeted, potentially less toxic therapies such as CDK4/6 inhibitors. His team has launched a prospective multi-center, international clinical trial to test the correlation between RBsig and clinical outcome in older women with ER-positive/HER2-positive early breast cancer. Patients are randomized to receive standard neoadjuvant chemotherapy plus anti-HER2 treatment or a CDK4/6 inhibitor, letrozole (hormonal therapy), and anti-HER2 treatment.

What’s next: Dr. DiLeo and his team will continue to recruit patients to this clinical trial to assess RBsig and other biomarkers as indicators of clinical outcome in elderly breast cancer patients. Ongoing trials will help to inform treatment decisions for the care of older breast cancer patients by indicating which patients can forego chemotherapy for less toxic treatments (such as CDK4/6 inhibitors) while preserving optimum clinical outcomes.


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