NCT06797531

Brief Summary

This is a non-interventional, prospective, single-arm, observational study describing the real-world effectiveness, safety, and PRO and HCRU data of ribociclib combined with adjuvant ET under conditions of routine clinical practice in HR+/HER2- EBC in premenopausal, perimenopausal and postmenopausal women, or men in Saudi Arabia.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
177

participants targeted

Target at P50-P75 for all trials

Timeline
32mo left

Started Aug 2025

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress21%
Aug 2025Nov 2028

First Submitted

Initial submission to the registry

January 21, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 28, 2025

Completed
7 months until next milestone

Study Start

First participant enrolled

August 27, 2025

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2028

Last Updated

February 4, 2026

Status Verified

February 1, 2026

Enrollment Period

3.3 years

First QC Date

January 21, 2025

Last Update Submit

February 2, 2026

Conditions

HR+/HER2- Early Breast Cancer

Keywords

Early breast cancerSaudi ArabiaRibociclibEffectivenessSafetyReal world evidenceRWEObservational study

Outcome Measures

Primary Outcomes (1)

  • Invasive Breast Cancer-Free Survival (iBCFS)

    iBCFS, defined as the time from the date of first dose to the date of the first event of invasive ipsilateral breast tumor recurrence, local/regional invasive recurrence, distant recurrence, death (any cause), or invasive contralateral BC. iBCFS will be assessed using STEEP Version 2.0 criteria (Standardized Definitions for Efficacy Endpoints in Adjuvant BC Clinical Trials), as assessed by the investigator, in patients with HR+/HER2- Anatomic Stage Group IIA(subset)/IIB/III EBC.

    36 months

Secondary Outcomes (10)

  • Invasive disease free survival (iDFS)

    Up to 36 months

  • Distant disease free survival (DDFS)

    Up to 36 months

  • Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)

    36 months

  • Change from baseline in the physical functioning sub-scale score and global health status/QoL scale score as assessed by EORTC QLQ-C30

    36 months

  • Demographics - Age

    Baseline

  • +5 more secondary outcomes

Study Arms (1)

Ribocliclib

HR+/HER2- early breast cancer patients who have been newly receiving ribociclib for up to 6 months prior to enrollment

Drug: ribociclib

Interventions

ribociclibDRUG

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

Ribocliclib

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

HR+/HER2- early breast cancer in premenopausal, perimenopausal, and postmenopausal women or men in Saudi Arabia.

You may qualify if:

  • Signed and dated Patient Informed Consent Form (PICF) obtained.
  • The patient is ≥ 18 years-old at the time of PICF signature.
  • Male or female patients with estrogen-receptor-positive and/or progesterone-receptor-positive BC.
  • Male or female patients with HER2- BC.
  • Patients who are currently receiving ribociclib in combination with adjuvant ET as per approved local label for up to 6 months prior the enrollment date.
  • Male or female patients with American Joint Committee on Cancer (AJCC) Anatomic Stage Group IIA(subset) /IIB or Anatomic Stage Group III EBC.
  • Female patients with known menopausal status (at the time of PICF signature or initiation of adjuvant ET, whichever occurs earlier), or male.

You may not qualify if:

  • Ribociclib-based treatment regimen beyond adjuvant therapy for EBC.
  • Patients are currently participating in any other clinical trials.
  • Patients who previously received any other CDK4/6 inhibitor.
  • Patients who refused to sign informed consent.
  • According to the investigator's opinion, the patient is an unlikely candidate to provide an accurate medical history and/or to obtain long-term follow-up information for any reason.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Novartis Investigative Site

Riyadh, 11211, Saudi Arabia

RECRUITING

Novartis Investigative Site

Riyadh, 11426, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

ribociclib

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 21, 2025

First Posted

January 28, 2025

Study Start

August 27, 2025

Primary Completion (Estimated)

November 30, 2028

Study Completion (Estimated)

November 30, 2028

Last Updated

February 4, 2026

Record last verified: 2026-02

Locations

SA(2)