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 (IRINA)

Novartis

Status: Completed

Conditions: Breast Cancer

Treatments: Other: ribociclib

Study type: Observational

Funder types: Industry

Identifiers

NCT07072013

CLEE011ADE10

Details and patient eligibility

About

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

Full 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).

Enrollment: 1,937 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

1,937 participants in 2 patient groups

tamoxifen±OFS external control arm

Description:

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

Treatment:

Other: ribociclib

Ribociclib+NSAI+OFS arm

Description:

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

Treatment:

Other: ribociclib