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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

550 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-07

Study Completion Date

2025-06-30

Brief Summary

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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.

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Detailed Description

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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%.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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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.

ribociclib

Intervention Type OTHER

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

Treatment plan represents the prescription.

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

ribociclib

Intervention Type OTHER

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

Treatment plan represents the prescription.

Interventions

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ribociclib

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

Treatment plan represents the prescription.

Intervention Type OTHER

Other Intervention Names

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CLEE011

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No