Evaluating Safety in Insulin-Requiring Diabetic Patients Receiving Inavolisib Plus Endocrine Therapy-Based Regimens in the Real World

Study summary

No information provided.

Study identification

• EU PAS number:
  EUPAS1000001124
• Study ID:
  1000001124
• Official title and acronym:
  Evaluating Safety in Insulin-Requiring Diabetic Patients Receiving Inavolisib Plus Endocrine Therapy-Based Regimens in the Real World
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  This is a retrospective cohort study of eligible patients receiving inavolisib-based regimens in the Flatiron Health Network over a 3 to 4-year period from 01 January 2026 to 31 December 2029. The purpose of this real-world data (RWD) study is to evaluate inavolisib (Itovebi) in patients with hormone receptor positive (HR+)/ human epidermal growth factor receptor 2–negative (HER2–), phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha isoform (PIK3CA)-mutated metastatic breast cancer who have insulin-requiring diabetes (both type 1 and type 2). This RWD study will focus on the incidence, severity and complications, and management of hyperglycemia, stomatitis, and diarrhea, which are identified adverse events (AEs) for inavolisib.
• Study status:
  Planned

Research institutions and networks

Institutions

F. Hoffmann-La Roche

Study timelines

Date when funding contract was signed

Planned:30/03/2026

Actual:30/03/2026

Study start date

Planned:31/10/2026

Data analysis start date

Planned:31/12/2029

Date of final study report

Planned:31/12/2030

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

F. Hoffmann-La Roche

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)

Other study registration identification numbers and links

GO46271