Clinical trial · Observational
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
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ribociclib | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- tamoxifen±OFS external control arm
- description
- data were retrieved from the CLEAR-B study, provided by Institut für Frauengesundheit GmbH, Erlangen
- interventionNames
- Other: ribociclib
- label
- Ribociclib+NSAI+OFS arm
- description
- Ribociclib+NSAI+OFS data for premenopausal women were sourced from NATALEE trial data
- interventionNames
- Other: ribociclib
Primary outcomes (6)
- measure
- Invasive Disease-Free Survival (iDFS)
- timeFrame
- 96 months
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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 excludedReferences
Publications (0)
Data not yet available