An observational study in Breast Cancer, sponsored by Novartis Pharmaceuticals. Completed at 1 site in Germany. Open to female participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-07-18.
Sponsored by Novartis Pharmaceuticals · Observational
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
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).
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This study's enrollment of 1,937 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
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premenopausal women
Inclusion Criteria:
Patients must belong to one of the following categories according to the American Joint Committee on Cancer (AJCC):
Anatomic Stage Group IIA that it either:
Grade 2, with any of the following criteria:
data were retrieved from the CLEAR-B study, provided by Institut für Frauengesundheit GmbH, Erlangen
Other: ribociclib
Ribociclib+NSAI+OFS data for premenopausal women were sourced from NATALEE trial data
Other: ribociclib
This is an observational study. There is no treatment allocation. The decision to initiate ribociclib was based solely on clinical judgement.
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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 96 months
Plan to share: 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
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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