Study to Determine the Safety and Efficacy of Ribociclib in Combination With Hormone Therapy and Hypofractionated Radiotherapy in Breast Cancer, With Positive Hormone Receptors and Negative HER2 Status, in Newly Diagnosed, Not Immediately Operable Elderly Patient (CALHYS)

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

85

Participants

Timeline

Start Date

June 26, 2023

Primary Completion Date

October 31, 2031

Study Completion Date

March 31, 2033

Conditions
HER2 Negative Breast Cancer Not Immediately Operated
Interventions
DRUG

Ribociclib Oral Tablet

"600mg per day during registration phase (3 cycles); de-escalation phase (600 to 200mg per day associated to radiotherapy) during 3 other cycles; maintenance phase until 24 months of treatment in total (600mg per day).~All over th etimme, hormonotherapy is received in concomitance"

Trial Locations (1)

06189

RECRUITING

Centre Antoine Lacassagne, Nice

All Listed Sponsors
lead

Centre Antoine Lacassagne

OTHER