Breast CancerIRINANCT07072013
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 observational study of Breast Cancer, run by Novartis Pharmaceuticals at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- ribociclib
- How many people
- 1,937 participants
- Where
- 1 siteGermany
- Study dates
- 8 Sep 2023to 24 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Study population: premenopausal women
Who may be able to join
- 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:
Show all 17Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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)
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
Read the 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
- Being tested
- ribociclib
- Keywords
- Ribociclib,, early breast cancer,, indirect treatment comparison,, tamoxifen,, premenopausal
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ribociclibOther
This is an observational study. There is no treatment allocation. The decision to initiate ribociclib was based solely on clinical judgement.
| Study group | Role | What they receive |
|---|---|---|
| tamoxifen±OFS external control arm | data were retrieved from the CLEAR-B study, provided by Institut für Frauengesundheit GmbH, Erlangen Receives: Other: ribociclib | |
| Ribociclib+NSAI+OFS arm | Ribociclib+NSAI+OFS data for premenopausal women were sourced from NATALEE trial data Receives: Other: ribociclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Invasive Disease-Free Survival (iDFS)
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).
Measured: 96 months
Distant Disease-Free Survival (dDFS)
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).
Measured: 96 months
Recurrence-Free Survival (RFS)
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.
Measured: 96 months
Overall Survival (OS)
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.
Measured: 96 months
Treatment Terminations (TT)
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.
Measured: 96 months
Treatment Terminations due to Toxicity (TT_Tox)
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.
Measured: 96 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start8 Sep 2023
- Primary completion24 Apr 2025
- Study completion24 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,937 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07072013
- Sponsor's protocol ID
- CLEE011ADE10
- Acronym
- IRINA
- Status last verified
- Jul 2025
- First submitted
- 16 Jul 2025
- Last updated
- 18 Jul 2025
- Results posted
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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)
- ClinicalTrials.gov ID
- NCT07072013
- Acronym / sponsor ID
- IRINA / CLEE011ADE10
- Conditions
- Breast Cancer
- Keywords
- Ribociclib,, early breast cancer,, indirect treatment comparison,, tamoxifen,, premenopausal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,937 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 8 Sep 2023 (actual)
- Primary completion
- 24 Apr 2025 (actual)
- Study completion
- 24 Apr 2025 (actual)
- First posted
- 18 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tamoxifen±OFS external control arm | – | Other: ribociclibdata were retrieved from the CLEAR-B study, provided by Institut für Frauengesundheit GmbH, Erlangen |
| Ribociclib+NSAI+OFS arm | – | Other: ribociclibRibociclib+NSAI+OFS data for premenopausal women were sourced from NATALEE trial data |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- premenopausal women
Key inclusion criteria (17 listed)
- 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):
- Grade 3
- Grade 2, with any of the following criteria:
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ribociclibThis is an observational study. There is no treatment allocation. The decision to initiate ribociclib was based solely on clinical judgement. | Other | Ribociclib+NSAI+OFS arm, tamoxifen±OFS external control arm |
Primary outcome
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).
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).
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Novartis Pharmaceuticals at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Invasive Disease-Free Survival (iDFS) (time frame: 96 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.