Phase II “proof of concept” Study, randomized 1:1, to evaluate whether dapagliflozin reduces chemotherapy induced cardiotoxicity in participants with breast cancer treated with (neo-) adjuvant Anthracycline-based chemotherapy +/- trastuzumab, study is national multicentered

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-518611-18-00

Enrollment

316

Registered

2024-12-03

Start date

Unknown

Completion date

Unknown

Last updated

2025-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chemotherapy-induced cardiotoxicity in breast cancer

Brief summary

to assess whether the administration of dapagliflozin is associated with a lower rate of asymptomatic and symptomatic CTRCD during 18 months during a 18 months follow-up

Detailed description

to assess whether the administration of dapagliflozin is associated with a lower rate of asymptomatic CTRCD during 18 months

Interventions

DRUGForxiga 10 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
to assess whether the administration of dapagliflozin is associated with a lower rate of asymptomatic and symptomatic CTRCD during 18 months during a 18 months follow-up	—

Secondary

Measure	Time frame
to assess whether the administration of dapagliflozin is associated with a lower rate of asymptomatic CTRCD during 18 months	—

Countries

Italy

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026