Home » ABCSG Studies » Studies open for Enrollment » ABCSG 67N / CAROLEEN » ABCSG 67N / CAROLEEN Study Details *

ABCSG 67N / CAROLEEN Study Details *


 A non-interventional study for ribociclib in combination with an aromatase inhibitor for adjuvant treatment in patients with HR+/HER2- early breast cancer at high risk of recurrence to evaluate real-world effectiveness, safety profile, patient compliance and quality of life

Study start: global Q1/2025
national Q4/2025
Coordinating Investigator: Christian Singer, Austria
Planned Participants: 3250 (Austria, Germany)
Study Design :
(Click to enlarge)		 ABCSG 67N / CAROLEEN

Treatment:

Section 1 („Cross-sectional“)

  • Parameters leading to the treatment decision between
  • ET Mono± LHRH, Ribociclib + AI± LHRH and Abemaciclib + ET ± LHRHand possible changes between the first and second year of enrollment of a total enrollment period of 2 years

Section 2 („Longitudinal“)

  • iDFS (invasive disease-free survival) in adjuvant treatment with Ribociclib + AI ± LHRH after 36 months (in the total population and in subgroups of special interest, e.g. N0)
  • Description of adherence and quality of life using questionnaires during adjuvant treatment with Ribociclib + AI ± LHRH and abemaciclib + ET± LHRH

Therefore, this study comprises a cross-sectional observation (section 1) at baseline and a longitudinal follow-up for a subset of the patients (section 2).

Primary objective:

  • Primary objective is to evaluate iDFS for adjuvant therapy with ribociclib + AI ± LHRH in patients with HR+/HER2- eBC at 36 months (section 2).

Patient Population:

  • Adult female and male patients with an indication for adjuvant treatment with ribociclib + AI ± LHRH in HR+/HER2- eBC at high risk of recurrence as described in the Summary of Product Characteristics (SmPC)

* Study information is displayed as described in study protocol V01. Sites must adhere to the currently approved version of the protocol.


Share on


Top