Low Dose TamOxifen and LifestylE Changes for bReast cANcer prevenTion

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

June 21, 2024

Primary Completion Date

December 31, 2025

Study Completion Date

January 31, 2026

Conditions
BRCA MutationPALB2 Gene MutationDuctal Carcinoma in SituLobular Carcinoma in SituATM Gene MutationCHEK2 Gene MutationCDH1 Gene MutationRAD51C Gene MutationRAD51D Gene Mutation
Interventions
DRUG

Tamoxifen 10 mg Tablet

One tablet of Tamoxifen 10 mg every other day for 6 months

OTHER

Intermittent caloric restriction

"5:2 diet: 5 days a week at regular energy intake and 2 days/week at 75% energy deficit (diet will be restricted at 500-800 kcal corresponding to a 75% reduction compared to normal size)"

BEHAVIORAL

Step counter Device

Participants will receive personal advice on healthy lifestyle and a step counter

Trial Locations (4)

20141

Istituto Europeo di Oncologia, Milan

Unknown

E.O. Galliera, Genoa

Istituto Nazionale Tumori G. Pascale, Napoli

Istituto Oncologico Veneto, Padua

All Listed Sponsors
collaborator

Ente Ospedaliero Ospedali Galliera

OTHER

collaborator

Istituto Oncologico Veneto IRCCS

OTHER

collaborator

Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale

NETWORK

lead

European Institute of Oncology

OTHER