A Real-World Study of Treatment Patterns, Tolerability and Effectiveness of CDK4/6 Inhibition in … (NCT07760714) | Clinical Trial Compass
CompletedNot Applicable
A Real-World Study of Treatment Patterns, Tolerability and Effectiveness of CDK4/6 Inhibition in HR+, HER2-negative Metastatic Breast Cancer Patients
United States945 participantsStarted 2025-02-26
Plain-language summary
The aim of this study was to assess real-world treatment patterns and tolerability of ribociclib among patient populations historically underrepresented in clinical trials - specifically older adults and Black/African American patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer (mBC).
The study was conducted using data from a nationwide database derived from electronic health record (EHR) data collected from oncology practices across the United States. The study population was drawn from community and academic oncology practices within the health research network.
Who can participate
Age range
18 Years – 120 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Included in Flatiron's mBC Enhanced Data Model (EDM):
. Had an International Classification of Diseases (ICD) diagnosis of breast cancer (ICD, 9th revision, clinical modification \[ICD-9-CM\] 174.x or 175.x or ICD, 10th revision, clinical modification \[ICD-10-CM\] C50x)
. At least two documented clinical visits, on different days, occurring on or after January 1, 2011
. Included in probabilistic sample of patients queued for review via abstraction
. Had pathology consistent with breast cancer
. Had evidence of stage IV or recurrent mBC with a metastatic diagnosis date on or after January 1, 2011, including patients diagnosed as stage IV at initial diagnosis, or diagnosed with earlier stage disease who then developed metastatic disease
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Patients Who Initiated 1L Ribociclib Treatment for HR+/HER2- mBC, by Demographic and Clinical Characteristics Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older
Timeframe: Baseline
2
Age at 1L Ribociclib Initiation Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older
Timeframe: Baseline
3
Body Mass Index (BMI) at 1L Ribociclib Initiation Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older
Timeframe: Baseline
4
Number of Patients by Eastern Cooperative Oncology Group (ECOG) Performance Status Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older,
Timeframe: Baseline
5
Duration Between Metastatic Diagnosis and 1L Ribociclib Initiation Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older
Timeframe: Baseline
6
Number of Patients by Initial and Subsequent Dosing Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older
. Initiated treatment with first-line (1L) ribociclib (in combination with endocrine therapy \[ET\]) in the metastatic setting on or after January 1, 2018, and at least 6 months prior to the study data cutoff date (October 31, 2024) to ensure adequate time to observe dose modifications and treatment discontinuations
. Had evidence of HR+/HER2- test result prior to or up to 30 days after initiation of 1L ribociclib
Exclusion criteria
. Use of any CDK4/6 inhibitor therapy in combination with tamoxifen
. Use of any CDK4/6 inhibitor in the pre-metastatic setting
7
Number of Patients With Dose Modifications Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older
Timeframe: Up to approximately 6 years, 10 months
8
Number of Patients by Reasons for Dose Modifications Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older
Timeframe: Up to approximately 6 years, 10 months
9
Number of Patients Who Discontinued Treatment Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older
Timeframe: Up to approximately 6 years, 10 months
10
Number of Patients by Reason for Treatment Discontinuation Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older