“Palbociclib plus Aromatase- inhibitor as first-line treatment for Hormone Receptor (HR)-positive /Human Epidermal Growth Factor Receptor 2 (HER2)-negative locally advanced or metastatic breast cancer patients in Italy: a retrospective observational study (Palbo-Italy)”

Study identification

• EU PAS number:
  EUPAS1000000352
• Study ID:
  1000000352
• Official title and acronym:
  “Palbociclib plus Aromatase- inhibitor as first-line treatment for Hormone Receptor (HR)-positive /Human Epidermal Growth Factor Receptor 2 (HER2)-negative locally advanced or metastatic breast cancer patients in Italy: a retrospective observational study (Palbo-Italy)”
• DARWIN EU® study:
  No
• Study countries:
  Italy
• Study description:
  CDK4/6-inhibitors are the standard of care as first line treatment of HR+/HER2- locally advanced (LA) or metastatic breast cancer (MBC) patients 9-11, as a consequence of positive results from large phase III trials showing a statistically significant and clinically meaningful progression-free survival (PFS) benefit favoring these agents compared to endocrine therapy (ET) alone 16, 38-40. Based on existing evidences, the Italian Regulatory Agency (AIFA) authorized the reimbursement of Palbociclib, Ribociclib and Abemaciclib in combination with endocrine therapy for the treatment of HR+/HER2- LA/MBC patients in 2017 41, 2018 42,43 e 2019 44 respectively. ; Patient populations in the real-world setting can vary from those enrolled in clinical trials. Real-world studies provide the unique opportunity to generate evidences on clinical benefit of oncological treatments in a broader population compared to highly-selected patients enrolled in randomized controlled trials (RCT), adding complementary information 45-48. Multiple factors are contributing to the increased interest in RWE, including changes in technology and advancing analytical methods 49, novel types and variety of RWD 50 and the increasing acceptance of RWE from regulatory agencies, Health Technology Assessment (HTA) bodies, and payers 49, 51-55.; For these reasons, the collection of effectiveness and safety data of approved drugs is of clinical interest and can help the decision-making process at many levels.; In Italy there is not a National Cancer Registry to collect structured real-world data on licensed drugs, but there is a clinical need to collect local real-world data to provide a picture of Italian breast cancer usual care. Although there are many real-world studies evaluating palbociclib in the real-life context, the Italian population is often absent or underrepresented.
• Study status:
  Planned

Research institutions and networks

Institutions

Pfizer

Study timelines

Date when funding contract was signed

Planned:25/02/2025

Study start date

Planned:01/12/2025

Data analysis start date

Planned:01/12/2025

Date of final study report

Planned:25/01/2027

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Pfizer

Regulatory

• Was the study required by a regulatory body?:
  Unknown
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable