A Study of Ribociclib in Combination With Hormonal Therapy in HR+/HER2- Advanced or Metastatic Breast Cancer

Real-World Evidence Study for the Safety and Effectiveness of Ribociclib in Combination With Hormonal Therapy in Patients With HR+/HER2- Advanced or Metastatic Breast Cancer in the Middle East Region

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Other: ribociclib

Detailed Description

The investigators will have a six-month recruitment period to include the eligible subjects as per the protocol selection criteria. 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.

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.

Data will be collected from patient electronic medical records in the sites chosen for patients who received Ribociclib, in combination with hormonal therapy, in the first or second-line setting available in the relevant institutions.

A total of 550 patients is planned for this study. The planned sample size should capture very common adverse events reported in previous studies as well as adverse events ≥ 10% occurring in grade 3 and grade 4 with precision ±2.5%.

• Study Type: Observational
• Enrollment (Estimated): 550

Contacts and Locations

• Study Contact: Name: Novartis Pharmaceuticals; Phone Number: +41613241111; Email: novartis.email@novartis.com
• Study Contact Backup: Name: Novartis Pharmaceuticals

Study Locations

• Jordan
  • Amman, Jordan, 11941
    • Recruiting
    • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability 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

Description

Inclusion Criteria:

1. Adult patients ≥ 18 years old at the time of receiving Ribociclib in combination with hormonal therapy.
2. Advanced /metastatic breast cancer
3. Estrogen-receptor-positive and/or progesterone receptor-positive breast cancer.
4. HER2-negative breast cancer.
5. Patients who received or currently receiving Ribociclib in combination with hormonal therapy in the first or second-line settings as per the routine practice.
6. 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.
7. 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
8. For ambispective part, patients agree to sign informed consent before their enrollment.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; There is no treatment allocation for NIS trials, patients on administered ribociclib by prescription will be enrolled. Treatment plan represents the prescription.; Other Names: CLEE011
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; There is no treatment allocation for NIS trials, patients on administered ribociclib by prescription will be enrolled. Treatment plan represents the prescription.; Other Names: CLEE011

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients who are progression-free	Percentage of progression-free patients (at 18 months following the start date of ribociclib and at the end of ribociclib treatment),	6 months, 18 months
Proportion of patients with clinical benefit response	Tthe proportion of patients who have a partial or complete response or stable disease(CBR) with Ribociclib at 18 months based on Response Evaluation Criteria in Solid Tumors RECIST v1.1	18 months
Ribociclib line of therapy treatment pattern	Ribociclib line of therapy treatment pattern at 18 months	18 months

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2024
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): November 30, 2024

Study Registration Dates

• First Submitted: October 4, 2023
• First Submitted That Met QC Criteria: October 4, 2023
• First Posted (Actual): October 10, 2023

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: NIS; Ribociclib; HR+/HER2- advanced/metastatic breast cancer; Middle eastern countries
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: CLEE011AIC01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO