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Luca Gianni, MD

Fondazione Michelangelo ONLUS
Milan, Italy

Titles and Affiliations

President, Gianni Bonadonna Foundation

Research area

Improving response to immunotherapy in triple-negative breast cancer.


Immunotherapies are a promising new class of cancer drugs designed to amplify the immune system to attack cancer cells. In breast cancer, triple-negative breast cancer has shown some response to immunotherapy when combined with chemotherapy, but the proportion of patients who benefit remains low. Consequently, some patients experience the side effects associated with immunotherapies, without the clinical benefit. Dr. Gianni and his team are investigating potential biomarkers for response to immunotherapy, to better predict which patients should receive these treatments.

Progress Thus Far

A clinical trial tested the combination of immunotherapy with chemotherapy in triple-negative breast cancer and was recently extended to high-risk HER2-positive breast cancer. Dr. Gianni’s team is analyzing the samples from these trials to understand the mechanism of immune resistance and sensitivity to develop better immunotherapy strategies. They have discovered that unique interactions between specific types of immune and tumor cells in these patients might inform who benefits most from immunotherapy.

What’s next

The team will continue to analyze the complex molecular and genetic data gleaned from these important trials to discover relevant and predictive biological indicators that indicate which patients would benefit from these types of immunotherapies.


Dr. Gianni is the Director of the Department of Medical Oncology and the head of the Project of Development of New Drugs and Innovative Therapies in Solid Tumours at the San Raffaele Scientific Institute in Milan, Italy. He also is the Cofounder and President of the Michelangelo Foundation, a non-profit organization designed to advance research in oncology, and chairman of the Michelangelo Breast Cancer Study Group. Recently Dr. Gianni also became the first President of the “Gianni Bonadonna Foundation” for innovative therapies for cancer. During his career Dr. Gianni has worked on new drug development in the field of oncology and on the definition of innovative drug therapies in Medical Oncology. Since 1995 he focused on clinical and translational research in women with breast cancer.

Dr. Gianni has conducted and contributed key research with anthracyclines and performed studies of drug disposition of several new anticancer agents. He founded the first Phase I Unit in Italy in 1983 upon return to work with Dr. Bonadonna at the Istituto Nazionale Tumori and led the phase I project there until he moved to San Raffaele in 2011. Since 1995 he has overseen the clinical and research activity related to breast cancer at the Istituto Nazionale and at the Fondazione Michelangelo.

Specifically related to breast cancer, Dr. Gianni has been involved in the development of paclitaxel. Dr. Gianni also served in the Executive Committee of the HERA trial, one of the first testing trastuzumab as adjuvant therapy. He launched and conducted the NOAH neo-adjuvant trial of chemotherapy and trastuzumab in women with locally advanced/inflammatory HER2-positive breast cancer, which proved the benefit of adding the monoclonal antibody in terms of eradication of local disease, event free survival and overall survival. The results were the basis for trastuzumab becoming the first approved neoadjuvant therapy in women with HER2-positive breast cancer in Europe.

More recently Dr. Gianni contributed to the design of the development of Pertuzumab in metastatic breast cancer, and designed and chaired the neoadjuvant trial known as NeoSphere, a collaboration of the Michelangelo Breast Cancer study group with Roche/Genentech, that brought to the approval of dual block of HER2 as neoadjuvant approach and to the design of the Aphinity adjuvant trial in women with HER2-positive early breast cancer. After establishing the profound differences of HER2-positive breast cancer depending on the status of the estrogen receptor in the HER2-positive tumor, Dr. Gianni and collaborators have documented the ability of obtaining major antitumor effects including several pathologic complete responses with a chemotherapy-free approach in women with HER2-positive/ER-positive operable breast cancer by combining trastuzumab and pertuzumab plus fulvestrant plus the CDK4/6 inhibitor palbociclib.

Dr. Gianni is recipient of several grants and research support and was awarded the “Gianni Bonadonna Award and Fellowship” by the American Society of Clinical Oncology in 2011.

BCRF Investigator Since


Donor Recognition

The Delta Air Lines Award

Areas of Focus

Treatment Tumor Biology