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