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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tamoxifen±OFS external control arm | data were retrieved from the CLEAR-B study, provided by Institut für Frauengesundheit GmbH, Erlangen |
| |
| Ribociclib+NSAI+OFS arm | Ribociclib+NSAI+OFS data for premenopausal women were sourced from NATALEE trial data |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ribociclib | Other | This is an observational study. There is no treatment allocation. The decision to initiate ribociclib was based solely on clinical judgement. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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
| 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:
| 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
| 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. | 96 months |
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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:
Grade 3
Grade 2, with any of the following criteria:
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premenopausal women
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis investigative site | München | 80333 | Germany |
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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| 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. |
| 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. | 96 months |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000589651 | ribociclib |
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