Anti-hormonal Therapie With Ribociclib in HR-positive / HER2- Negative Metastatic Breast Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

56

Participants

Timeline

Start Date

March 15, 2018

Primary Completion Date

July 21, 2022

Study Completion Date

July 21, 2022

Conditions
Breast Cancer Metastatic
Interventions
DRUG

Ribociclib

Ribociclib in addition to endocrine maintenance therapy. Endocrine therapy, at the discretion of the investigator, could have already been started up to 4 weeks before randomization but not later than with first dose of ribociclib.

DRUG

Anastrozole

1mg once daily as indicated in the SmPC

DRUG

Letrozole

2,5mg once daily as indicated in the SmPC

DRUG

Exemestane

25mg once daily as indicated in the SmPC

DRUG

Fulvestrant

(prefilled syringes with fulvestrant 250mg each), 500mg given once a month, with an additional 500mg dose given two weeks after the first dose as indicated in the SmPC

Trial Locations (1)

88212

Studienzentrum Onkologie Ravensburg, Ravensburg

All Listed Sponsors
lead

GBG Forschungs GmbH

OTHER

NCT03555877 - Anti-hormonal Therapie With Ribociclib in HR-positive / HER2- Negative Metastatic Breast Cancer | Biotech Hunter | Biotech Hunter