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 identification

• EU PAS number:
  EUPAS1000000805
• Study ID:
  1000000805
• Official title and acronym:
  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)
• DARWIN EU® study:
  No
• Study countries:
  Denmark

  France

  Germany

  United States
• Study description:
  This is a non-interventional, longitudinal, capivasertib + fulvestrant new-user cohort study that will use secondary data (administrative claims, electronic medical records [EMR] and/or registries) from multiple EU member states (France, Germany, Denmark) and the United States of America (USA) to further characterize the safety and effectiveness of capivasertib + fulvestrant in patients with breast cancer and diabetes. The main objectives 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. The study will include two distinct cohorts: a safety cohort for assessing safety outcomes and an effectiveness cohort for evaluating effectiveness outcomes.
• Study status:
  Planned

Research institutions and networks

Institutions

AstraZeneca

Aetion

Spain

Study timelines

Date when funding contract was signed

Planned:01/03/2025

Actual:13/01/2025

Study start date

Planned:01/10/2026

Data analysis start date

Planned:01/01/2027

Date of interim report, if expected

Planned:30/09/2027

Date of final study report

Planned:30/09/2030

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Study is sponsored by AstraZeneca.

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)