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Luca Gianni, MD

President, Gianni Bonadonna Foundation
Fondazione Michelangelo ONLUS
Milan, Italy

Current Research

Goal: To improve response to immunotherapy in triple-negative breast cancer (TNBC).

Impact: Dr. Gianni has advanced the understanding of how chemotherapy given before surgery (called neoadjuvant therapy) can trigger the immune system to attack and eliminate TNBC tumors. This work, along with his research of biomarkers that could predict response to immunotherapy, may help determine which patients would benefit from chemotherapy alone and those who would have a better response to a combination of chemotherapy and immunotherapy. 

What’s next: He and his team are launching a clinical trial in patients with early high-risk and locally advanced TNBC. They will compare the effects of adding an immunotherapy drug (atezolizumab) with chemotherapy versus chemotherapy alone. 

In clinical trials, immunotherapy has shown some success in treating TNBC. However, the response rate is low, which may be due to the lack of biomarkers that would help doctors predict which patients may benefit from this targeted form of therapy. Dr. Gianni is studying methods to identify those most likely to respond to a type of immunotherapy called immune-checkpoint inhibitors and those who will do well with chemotherapy alone.

Full Research Summary

Research area: Seeking biomarkers that could be used to improve response to immunotherapy in triple-negative breast cancer (TNBC).

Impact: While TNBC has shown some response to immunotherapy, the number of patients who benefit from the addition of these treatments to chemotherapy remains low. As a result, many patients who undergo this combination therapy may not benefit and experience undue toxicity. Dr. Gianni’s investigations into biomarkers that predict response to immunotherapy could enable doctors to tailor the administration of these drugs, both decreasing clinical toxicity and costs of treatment.

Current investigation: Dr. Gianni is testing an immune-related gene signature (IRS) developed by his team to identify TNBC patients most likely to benefit from a class of immune-targeting drugs called immune checkpoint inhibitors (ICIs). While some patients receive benefit from these drugs, there are no validated biomarkers to predict which patients are most likely to benefit,  which may explain why clinical trials have not shown a benefit in more patients. 

What he’s learned so far: Dr. Gianni has assessed the immune landscape of TNBC samples that will inform the upcoming clinical trial. He and his team have completed enrollment into a neoadjuvant phase III clinical trial testing the ICI atezolizumab in combination with the chemotherapy drugs nab-paclitaxel and carboplatin compared to chemotherapy alone in patients with early high-risk and locally advanced triple-negative breast cancer. 

What’s next: Dr. Gianni now aims to discover and validate other potential biomarkers to identify who will benefit from the addition of ICIs to chemotherapy and who will do well with chemotherapy alone. They will also continue to contribute to the knowledge of tumor-immune cell interaction, which would enable them to design new and better-focused immunotherapy trials in TNBC.


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 organisation 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 been in charge of 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+ early breast cancer. After establishing the profound differences of HER2+ breast cancer depending on the status of the estrogen receptor in the HER2+ 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+/ER+ 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. 

Grid Reasercher Headshot - Lucca Gianni

BCRF Investigator Since


Donor Recognition

The Delta Air Lines Award

Area(s) of Focus