Safety and Effectiveness of Capivasertib with Fulvestrant in Patients with Advanced Breast Cancer and Diabetes – a Multi-country Observational Study using Secondary Real-World Data (CAPIseid)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  TRUQAP
• Anatomical Therapeutic Chemical (ATC) code:
  (L01EX27) capivasertib

  capivasertib

  (L02BA03) fulvestrant

  fulvestrant
• Medical condition to be studied:
  Breast cancer

Population studied

• Short description of the study population:
  The study population will consist of all adults with diabetes mellitus and breast cancer in the ; selected secondary data sources who, during the accrual period, initiate treatment with ; capivasertib + fulvestrant (index date)

Study design details

• Study design:
  This non-interventional, longitudinal, capivasertib + fulvestrant new-user cohort study will use secondary data (administrative claims, electronic medical records [EMR] and/or registries) from multiple EU member states and the USA.
• Main study objective:
  The main objectives of this non-interventional study are to assess (i) the risk of acute complications of hyperglycaemia (including diabetic ketoacidosis) and (ii) time to first subsequent therapy (TFST) or death due to any cause in adult patients with advanced breast cancer and type 1 or type 2 diabetes receiving capivasertib + fulvestrant treatment.
• Outcomes:
  Outcomes; • Primary outcomes:; o Safety: Acute complications of hyperglycaemia (composite), including diabetic; ketoacidosis; o Effectiveness: TFST; • Secondary outcomes:; o rwOS; o TTD; • Exploratory outcomes:; o rwPFS; o Time-to-acute complications of hyperglycaemia (composite), including diabetic; ketoacidosis; PASS Protocol AstraZeneca; Capivasertib, D3612R00020 2.0, 02 June 2025; 21 of 210; o Acute complications of hyperglycaemia (composite), including diabetic; ketoacidosis, stratified by insulin-dependent diabetes and non-insulin-dependent; diabetes; o TFST stratified by insulin-dependent diabetes and non-insulin-dependent diabetes; o rwOS stratified by insulin-dependent diabetes and non-insulin-dependent diabetes; o Primary safety outcome (acute complications of hyperglycaemia [composite],; including diabetic ketoacidosis) and effectiveness outcome (TFST) in patients; with ER+/HER2- advanced breast cancer with ≥1 PIK3CA/AKT1/PTEN; alteration10; o Primary safety outcome (acute complications of hyperglycaemia [composite],; including diabetic ketoacidosis) in patients with a recorded baseline HbA1c level; ≥ 8.0%; o Individual components of the primary safety outcome: Diabetic ketoacidosis and; hyperosmolar hyperglycaemic syndrome; o Anti-diabetic treatment patterns