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

Recruiting

• Conditions: Breast Cancer
• Interventions: Other: ribociclib

• Registration Number: NCT06075758
• Lead Sponsor: Novartis Pharmaceuticals

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.

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 Timeline

• Study First Submitted: 2023-10-04
• Study First Submitted QC: 2023-10-04
• Study First Posted: 2023-10-10
• Study Start: 2024-03-07
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-11
• Last Update Posted: 2025-01-14
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 550

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ribociclib ambispective	ribociclib	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.
ribociclib retrospective	ribociclib	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

Primary Outcome Measures

Name	Time	Method
AEs/SAEs/ severity and frequency	18 months	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.

Secondary Outcome Measures

Name	Time	Method
Ribociclib line of therapy treatment pattern	18 months	Ribociclib line of therapy treatment pattern at 18 months
Proportion of patients who are progression-free	6 months, 18 months	Percentage of progression-free patients (at 18 months following the start date of ribociclib and at the end of ribociclib treatment),
Proportion of patients with clinical benefit response	18 months	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

Trial Locations

Locations (1)

Novartis Investigative Site; 🇦🇪 Al Ain Abu Dhabi, United Arab Emirates