Time restricted Eating And Metformin (TEAM) in invasive breast cancer (IBC) or ductal carcinoma in situ (DCIS). A randomized, phase IIb, window of opportunity presurgical trial.

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-518402-40-00

Enrollment

Registered

2024-11-25

Start date

Unknown

Completion date

Unknown

Last updated

2025-03-26

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

Conditions

Luminal (ER+ve and/or PgR+ve >=1%) invasive breast cancer or ductal carcinoma in situ

Brief summary

Frequency of occurrence of dose limiting toxicity in the first 14 patients in the experimental arm (interim endpoint); change in pre-post treatment immunohistochemical Ki67 LI in IBC or DCIS (in the absence of IBC) (primary) and difference in post-treatment adjacent DCIS (in the presence of IBC), if present, or IEN (defined as ADH/ALH/LCIS) Ki67 (co-primary) between arms.

Interventions

DRUGGLUCOPHAGE UNIDIE 750 mg compresse a rilascio prolungato

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Frequency of occurrence of dose limiting toxicity in the first 14 patients in the experimental arm (interim endpoint); change in pre-post treatment immunohistochemical Ki67 LI in IBC or DCIS (in the absence of IBC) (primary) and difference in post-treatment adjacent DCIS (in the presence of IBC), if present, or IEN (defined as ADH/ALH/LCIS) Ki67 (co-primary) between arms.	—

Countries

Italy

Outcome results

None listed

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