“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 type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  retrospective observational study
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  IBRANCE
• Study drug International non-proprietary name (INN) or common name:
  PALBOCICLIB
• Anatomical Therapeutic Chemical (ATC) code:
  (L01EF01) palbociclib

  palbociclib
• Medical condition to be studied:
  Breast cancer

Population studied

• Short description of the study population:
  HR+/HER2- locally advanced or metastatic breast cancer patients treated in first-line with palbociclib+aromatase inhibitor (+/- LHRH analog according to menopausal status) between January 1st, 2018 and June 30th, 2022 in Italy.

Study design details

• Study design:
  Non-interventional, retrospective, single arm cohort study in Italy.
• Main study objective:
  Real-world time to treatment discontinuation for patients treated with palbociclib+aromatase inhibitor as 1st line treatment
• Setting:
  This retrospective observational study aims to include HR+/HER2- locally advanced or metastatic breast cancer patients treated with palbociclib + aromatase inhibitor as 1st line treatment between January 1st , 2018 and June 30th, 2022 at approximately 12 sites across all Italian territory. The estimated sample size is of approximately 600 patients. Eligible patients must meet Italian reimbursed indications and inclusion criteria. Patients will be evaluated for eligibility in a consecutive way across the study period. Patients who switched to palbociclib as a consequence of inacceptable toxicity from another CDK4/6-inhibitor are excluded to avoid confounders in the evaluation of the primary endpoint.