Observational multicentric national longitudinal study evaluating Ibrance (palbociclib) in a real life setting conditions in patients 70 years old and older presenting a locally advanced or metastatic HR+/HER2- breast cancer (PalomAGE)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation

  Effectiveness study (incl. comparative)

  Other
• If ‘other’, further details on the scope of the study:
  Feasibility of treatment

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

Population studied

• Short description of the study population:
  La cohort A (n=387) is considered as hormonosentive population and will include patient who received prior adjuvant hormone therapy with no relapse during or within one year of the end of adjuvant hormone therapy And /Or patient who didn’t received any prior systemic treatment for their advanced disease. Cohort B (n= 400) is considered as population that can’t be included in cohort A
• Age groups:
  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  787

Study design details

• Main study objective:
  Evaluate the feasibility of palbociclib treatment in patients aged 70 years and older, and treated for metastatic HR+/HER2- breast cancer. The feasibility of the treatment will be evaluated in terms of treatment discontinuation at 6 months in Cohort B and at 18 months in Cohort A for the following reasons: progression, toxicity, patient choice, death.
• Outcomes:
  Treatment discontinuation at 6 months in Cohort B and at 18 months in Cohort A for the following reasons: progression, toxicity, patient choice, death. Time to treatment failure Factors associated with treatment discontinuation according to patients characteristics from DIALOG G CODE PFS, Radiological and clinical tumor response Safety Quality Of life :QLQC30 & EDL 14 Compliance and treatment modifications
• Data analysis plan:
  Population eligible and assessable for the primary criterion: eligible patients having received at least 1 cycle of palbociclib treatment. Analysis of outcome measures Each cohort (1st line and 2nd line and above) will be analysed independently. No statistical comparison will be performed between the two patient cohorts.

Documents

Study publications

Brain E, Grosjean J, Pulido M, Paillaud E, Carola E, Jovenin N, Guillem O, Cheh…