NCT06075758

Brief Summary

This is a non-interventional, ambispective, observational cohort study describing the real-world safety data of approximately 550 Hormone receptor / Human epidermal growth factor receptor 2 (HR+/HER2-) advanced/metastatic breast cancer patients who have received ribociclib combined with hormonal therapy in pre-and postmenopausal women or men in Middle Eastern countries.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
175

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2024

Geographic Reach
3 countries

3 active sites

Status
completed

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

First Submitted

Initial submission to the registry

October 4, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

March 7, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

May 6, 2026

Status Verified

May 1, 2026

Enrollment Period

1.3 years

First QC Date

October 4, 2023

Last Update Submit

May 5, 2026

Conditions

Breast Cancer

Keywords

HR+/HER2- advanced/metastatic breast cancerNISRibociclibMiddle eastern countries

Outcome Measures

Primary Outcomes (1)

  • AEs/SAEs/ severity and frequency

    Frequency/ severity of adverse events and lab abnormalities of HR+/HER2- advanced/metastatic breast cancer patients who have received Ribociclib in combination with hormonal therapy at 6and 18 months.

    18 months

Secondary Outcomes (3)

  • Proportion of patients who are progression-free

    6 months, 18 months

  • Proportion of patients with clinical benefit response

    18 months

  • Ribociclib line of therapy treatment pattern

    18 months

Study Arms (2)

ribociclib ambispective

Ambispective patients should have initiated Ribociclib, in combination with hormonal therapy, for at least 12 months before the patient's recruitment date and are still on Ribociclib in combination with hormonal therapy at recruitment. These patients will be followed up till progression, death, Ribociclib discontinuation due to adverse events, or till a maximum period of 6 months, whichever comes first.

Other: ribociclib

ribociclib retrospective

Retrospective patients should have been on Ribociclib in combination with hormonal therapy for at least 18 months and stopped the medication before the patient's recruitment

Other: ribociclib

Interventions

ribociclibOTHER

There is no treatment allocation for NIS trials, patients on administered ribociclib by prescription will be enrolled. Treatment plan represents the prescription.

Also known as: CLEE011
ribociclib ambispectiveribociclib retrospective

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

HR+/HER2- advanced/metastatic breast cancer patients who have received Ribociclib in combination with hormonal therapy in pre-and postmenopausal women or men in Middle Eastern countries

You may qualify if:

  • Adult patients ≥ 18 years old at the time of receiving Ribociclib in combination with hormonal therapy.
  • Advanced /metastatic breast cancer
  • Estrogen-receptor-positive and/or progesterone receptor-positive breast cancer.
  • HER2-negative breast cancer.
  • Patients who received or currently receiving Ribociclib in combination with hormonal therapy in the first or second-line settings as per the routine practice.
  • For the ambispective part, patients should have initiated the Ribociclib, in combination with hormonal therapy, line of treatment at least 12 months before the patient's recruitment date and still continuingcontinuing the drug at the baseline visit.
  • For retrospective patients only, the patients should have been on Ribocilib, in combination with hormonal therapy, for at least 18 months and stopped Ribociclib before the SIV date.enrollment
  • For ambispective part, patients agree to sign informed consent before their enrollment.

You may not qualify if:

  • Ribociclib-based treatment regimen beyond the second line.
  • Patients are currently participating in any other clinical trials.
  • Patient with a known hypersensitivity to any of the excipients of Ribociclib.
  • Patients who previously received any other CDK4/6 inhibitor .
  • For ambispective patients, patients who refuse to sign the informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Novartis Investigative Site

Amman, 11941, Jordan

Location

Novartis Investigative Site

Muscat, 111, Oman

Location

Novartis Investigative Site

Al Ain Abu Dhabi, United Arab Emirates, United Arab Emirates

Location

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

Study Design

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

Study Record Dates

First Submitted

October 4, 2023

First Posted

October 10, 2023

Study Start

March 7, 2024

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

May 6, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

OM(1)JO(1)AE(1)