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

NCT07072013 | Completed

• 1 other identifier: CLEE011ADE10
• Study Type: observational
• Target: 1,937
• Locations: 1 country
• Sites: 1

Brief 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. tamoxifen±OFS using patients treated in German routine care as external control

Conditions

Breast Cancer

Keywords

Ribociclib,; early breast cancer,; indirect treatment comparison,; tamoxifen,; premenopausal

Outcome Measures

Primary Outcomes (6)

• 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).

  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).

  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.

  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

• 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

Study Arms (2)

tamoxifen±OFS external control arm

data were retrieved from the CLEAR-B study, provided by Institut für Frauengesundheit GmbH, Erlangen

Other: ribociclib

Ribociclib+NSAI+OFS arm

Ribociclib+NSAI+OFS data for premenopausal women were sourced from NATALEE trial data

Other: ribociclib

Interventions

ribociclib OTHER

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

Ribociclib+NSAI+OFS arm; tamoxifen±OFS external control arm

Eligibility Criteria

• Age: 18 Years - 60 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

premenopausal women

You may qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis investigative site

München, 80333, Germany

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

ribociclib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: July 18, 2025
• Study Start: September 8, 2023
• Primary Completion: April 24, 2025
• Study Completion: April 24, 2025
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)