NEOadjuvant Abemaciclib and GIredestrant TriaL in Patients with ER-positive, HER2-negative Early Breast Cancer

PHASE2RecruitingINTERVENTIONAL
Enrollment

51

Participants

Timeline

Start Date

January 27, 2025

Primary Completion Date

April 1, 2026

Study Completion Date

April 1, 2027

Conditions
Breast Cancer
Interventions
DRUG

Abemaciclib 150 MG + Giredestrant 30 MG

Enrolled patients will receive 6 cycles of treatment in the absence of disease progression or unacceptable toxicity for a total of 24 weeks (2 weeks of opportunity phase and 22 weeks of neoadjuvant phase) before surgery

Trial Locations (8)

16132

NOT_YET_RECRUITING

IRCCS Ospedale Policlinico San Martino, Genova

33081

NOT_YET_RECRUITING

IRCCS Centro di Riferimento Oncologico (CRO), Aviano

35128

NOT_YET_RECRUITING

Istituto Oncologico Veneto IRCCS, Padua

80131

NOT_YET_RECRUITING

AOU Federico II, Napoli

RECRUITING

"Istituto Nazionale Tumori G. Pascale", Napoli

95045

NOT_YET_RECRUITING

Humanitas Istituto Clinico Catanese, Catania

00168

NOT_YET_RECRUITING

Fondazione Universitaria Policlinico Gemelli IRCCS, Roma

00186

NOT_YET_RECRUITING

Ospedale Fatebenefratelli - Isola Tiberina, Roma

All Listed Sponsors
lead

Fondazione Oncotech

OTHER