Safety Study of Adding Everolimus to Adjuvant Hormone Therapy in Women With High Risk of Relapse, ER+ and HER2- Primary Breast Cancer, Free of Disease After Receiving at Least One Year of Adjuvant Hormone Therapy

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

1,278

Participants

Timeline

Start Date

March 31, 2013

Primary Completion Date

June 30, 2020

Study Completion Date

June 30, 2030

Conditions
Primary Non-metastatic Breast CancerWho Remain Disease-free
Interventions
DRUG

Everolimus

(5 or 10 mg/day, i.e. 1 or 2 tablets/day)

DRUG

Placebo

(5 or 10 mg/day, i.e. 1 or 2 tablets/day)

Trial Locations (2)

Unknown

Centre Leon Berard, Lyon

Gustave Roussy, Villejuif

All Listed Sponsors
collaborator

Ministry of Health, France

OTHER_GOV

lead

UNICANCER

OTHER

NCT01805271 - Safety Study of Adding Everolimus to Adjuvant Hormone Therapy in Women With High Risk of Relapse, ER+ and HER2- Primary Breast Cancer, Free of Disease After Receiving at Least One Year of Adjuvant Hormone Therapy | Biotech Hunter | Biotech Hunter