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NCT Number: NCT07072013

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

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

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–60 year

Sex eligibility

Female

Study type

Observational

Primary location

Novartis investigative site

München, 80333, Germany

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ribociclib

Other

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

Primary outcomes

  1. Invasive Disease-Free Survival (iDFS)

    Time frame: 96 months

    Invasive Disease-Free Survival (iDFS) is defined as the time (in months) from the reference date to the date of the first contributing event and is censored otherwise.

    Contributing events according to the Standardized Definitions for Efficacy End Points (in Adjuvant Breast Cancer Trials) (STEEP) are

    • invasive ipsilateral breast tumor recurrence,
    • local/regional invasive recurrence,
    • distant recurrence,
    • death from BC,
    • death from non-BC cause,
    • death from unknown cause,
    • invasive contralateral BC,
    • or second primary non-breast invasive cancer (excluding basal and squamous cell carcinomas of the skin, or new in situ carcinomas of any site).

  2. Distant Disease-Free Survival (dDFS)

    Time frame: 96 months

    Distant Disease-Free Survival (dDFS) is defined as the time (in months) from the reference date to the date of first contributing event. Contributing events according to the STEEP criteria are:

    • distant recurrence
    • death from BC
    • death from a non-BC cause
    • death from an unknown cause or
    • a second primary non-breast invasive cancer (excluding basal and squamous cell carcinomas of the skin, or new in situ carcinomas of any site).

  3. Recurrence-Free Survival (RFS)

    Time frame: 96 months

    Recurrence-Free Survival (RFS) is defined as the time (in months) from the reference date to the date of the first contributing event and censored otherwise. Contributing events according to STEEP are

    • invasive ipsilateral breast tumor recurrence,
    • local/regional invasive recurrence,
    • distant recurrence,
    • death from BC,
    • death from a non-BC cause,
    • death from an unknown cause.

  4. Overall Survival (OS)

    Time frame: 96 months

    Overall survival (OS) is defined as the time (in months) from the reference date to the date of death from any cause. Time for censored patients is defined as the time from the reference date to last contact date.

  5. Treatment Terminations (TT)

    Time frame: 96 months

    For the ribociclib+NSAI+OFS arm, Treatment Termination (TT) is defined as permanent treatment termination of treatment.

    For the tamoxifen±OFS arm, TT is defined as permanent termination of adjuvant tamoxifen.

  6. Treatment Terminations due to Toxicity (TT_Tox)

    Time frame: 96 months

    For the ribociclib+NSAI+OFS arm, Treatment Termination due to Toxicity (TT_Tox) is defined as permanent treatment termination due to toxicity within three years of beginning ribociclib.

    For the tamoxifen±OFS arm, TT_Tox is defined as permanent treatment termination of adjuvant tamoxifen due to toxicity.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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)

Acronym: IRINA

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 18, 2025
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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