An Indirect Treatment Comparison of the Effectiveness of Ribociclib Combined With Non-steroidal Aromatase Inhibitors vs. Tamoxifen for the Adjuvant Treatment of Premenopausal Women With Hormon Receptor-positive, HER2-negative Early Breast Cancer

NCT ID: NCT07072013

Last Updated: 2025-07-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1937 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-08
• Study Completion Date: 2025-04-24

Brief Summary

The purpose of this indirect treatment comparison (ITC) was to generate comparative evidence on the effectiveness and safety in premenopausal women of ribociclib+Non-steroidal Aromatase Inhibitor (NSAI)+Ovarian Function Suppression (OFS) investigated in the global NATALEE trial (CLEE011O12301C, NCT 03701334) vs. tamoxifen±OFS using patients treated in German routine care as external control

Detailed Description

Data of premenopausal Early Breast Cancer (EBC) patients treated with tamoxifen±OFS in German routine care were used as external control for a patient-level adjusted ITC of ribociclib+NSAI+OFS vs. tamoxifen±OFS. The ribociclib+NSAI+OFS arm utilized data of premenopausal women in the NATALEE clinical trial. The tamoxifen±OFS arm as the external control used a subset of data collected in the CLEAR-B project (NCT05870813).

Conditions

Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

tamoxifen±OFS external control arm

data were retrieved from the CLEAR-B study, provided by Institut für Frauengesundheit GmbH, Erlangen

ribociclib

Intervention Type: OTHER

This is an observational study. There is no treatment allocation. The decision to initiate ribociclib was based solely on clinical judgement.

Ribociclib+NSAI+OFS arm

Ribociclib+NSAI+OFS data for premenopausal women were sourced from NATALEE trial data

ribociclib

Intervention Type: OTHER

This is an observational study. There is no treatment allocation. The decision to initiate ribociclib was based solely on clinical judgement.

Interventions

ribociclib

This is an observational study. There is no treatment allocation. The decision to initiate ribociclib was based solely on clinical judgement.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Premenopausal women between 18 and 60 years
• HR-positive, HER2-negative EBC without distant metastases
• Patients must belong to one of the following categories according to the American Joint Committee on Cancer (AJCC):

• Anatomic Stage Group III,
• Anatomic Stage Group IIB,
• Anatomic Stage Group IIA that it either:

• N1,
• N0 with the following criteria:
• Grade 3
• Grade 2, with any of the following criteria:

• Ki67 ≥ 20 % or
• Oncotype DX Breast Recurrence Score ≥ 26 or
• Prosigna/PAM50 categorized as high risk or
• MammaPrint categorized as high risk or
• EndoPredict EPclin Risk Score categorized as high risk.
• Patients with Cyclin-dependent Kinase 4/6 (CDK4/6) inhibitor treatment other than ribociclib+NSAI+OFS were excluded
• Patients in a bad general condition [Eastern Cooperative Oncology Group (ECOG) Status > 1] or with a limited life expectancy < 5 years were excluded

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis investigative site

München, , Germany

Countries

Germany

Other Identifiers

CLEE011ADE10

Identifier Type: -

Identifier Source: org_study_id