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

N/ACompletedNCT07072013

Novartis Pharmaceuticals1,937 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

1,937

Conditions

Breast Cancer

Interventions

ribociclibOTHER

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes