New Drugs and Early Drug Development for Innovative Therapies


The mission of our Division is to accelerate the development of new anticancer drugs (including biologics, and cellular therapies) that will improve survival and quality of life for patients with cancer.

Our personal commitment is devoted to build up an alternative, personalized, disease and pathway oriented model to develop drugs for cancer disease and to ensure equitable access to new and field-relevant health tools


Our Activities

The Division is strongly motivated to innovate approach to cancer treatment. Innovation refers to the testing and implementation of novel approaches (clinical trial designs and operations, funding mechanisms, resource utilization, data collection, data analysis, etc) to developing more effective therapeutics more efficiently than existing methods.

The Division is involved in a complex international network with cooperative efforts across institutions, industry, and organizations to conduct clinical trials that will have the greatest impact on cancer care more efficiently. The breadth and technical complexity of new technologies that could advance personalized oncology care demand a more interconnected approach to the development of diagnostics and therapeutics. Consortia of institutions that can standardize the acquisition, processing, and shipping of patient specimens may interconnect, with each having a laboratory that specializes in different methods of specimen analysis. Such interconnected facilities may expedite the development of personalized cancer therapeutics more powerfully than single centres.


The clinical research platform is based on:

  1. The speed and efficiency of the design, launch, and conduct of trials
  2. The innovation in science and trial design with strong translational background
  3. Trial prioritization, selection, support, and completion
  4. Dedicated clinical, pathology and laboratory platform integrated with a molecular screening program



  • Our staff

    New Drugs and Early Drug Development for Innovative Therapies


    Giuseppe Curigliano

    Staff New Drugs and Early Drug Development for Innovative Therapies

  • Clinical Trials


    • A phase 1b open-label three-arm multi-center study to assess the safety and tolerability of pf-05212384 (pi3k/mtor inhibitor)in combination with other anti-tumor agents.
    • A phase Ib, open-label study of oral BGJ398 in combinationwith oral BYL719 in adult patients with select advanced solidtumors.
    • A randomized pre-surgical pharmacodynamics study to assessthe biological activity of LEE011 plus letrozole versus singleagent letrozole in primary breast cancer (MONALEESA).
    • Phase 1B study of docetaxel + PF-03084014 in metastatic orlocally recurrent/advanced triple negative breast cancer.
    • A Phase 2, Single-Arm, Open-Label, Multicenter Study of theClinical Activity and Safety of Enzalutamide in Patients WithAdvanced, Androgen Receptor-Positive, Triple-Negative BreastCancer.
    • FINESSE An open, 3-cohort, phase II trial testing oral
    • administration of lucitanib in patients with FGFR1-amplified ornon-amplIfied oestrogen receptor positive metastatic breast cancer.
    • Pertuzumab + trastuzumab (PH) versus PH plus metronomicchemotherapy (PHM) in the elderly HER2+ metastatic breastcancer population who may continue on T-DM1 alone followingdisease progression while on PH / PHM: an open-label multicentre randomized phase II selection trial of the EORTCElderly TaskForce and Breast Cancer Group.
    • Phase 2, open-label, multicenter, randomized study of PD0332991 (oral CDK 4/6 inhibitor) monotherapy and PD0332991 (oral CDK 4/6 inhibitor) monotherapy and PD 0332991in combination with the endocrine therapy to which the patienthas progressed in the previous line for ER-positive, HER2 negative postmenopausal advanced breast cancer patients (TREND).
    • MEDI4736-1108 A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI4736 in Subjects with Advanced Solid Tumors.

  • Early Drug Development Research Program


Università degli Studi di Milano


Ministero della Salute Joint Commission International bollinirosa

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