RedClone
Intermittent capecitabine to reduce clonal evolution in patients with luminal B, HR-positive HER2- negative metastatic breast cancer treated with CDK4/6 inhibitors and aromatase-inhibitors.
II
interventionell
National
All Patients receive CDK4/6 inhibitors and aromatase inhibitor (AI). After 6 months of therapy Patients will be randomized 2:1 to the following arms: a) Experimental arm: alternating between capecitabine (7 days therapy followed by 7 days break) for 3 months and ribociclib+ aromatase inhibitor (AI) for 3 months. (In total for 1,5 years after randomization or until progressive disease, whichever occurs first). b) Standard Arm: continuous CDK 4/6 inhibitors and AI
Status: In Vorbereitung
Zeitraum
2025
2031
Zentren
30
Zentren gesucht
Patienten
200
06.09.2024
Klinische Settings
adjuvant
advanced treatment lin
palliativ
Beteiligte
AIO-Arbeitsgruppen
Sponsor
AIO-Studien-gGmbH
Förderer
Deutsche Krebshilfe
Identifier
AIO-MAM-0124
Kontakt
Leitung
Sarvenaz Yaghobramzi
Ansprechpartner*in
Sarvenaz Yaghobramzi
Telefon +49 30 450613448
E-Mail sarvenaz.yaghobramzi@charite.de