Metastatic Breast CancerNCT07148505
A Study of Real-world Outcomes Among Patients Treated With Ribociclib
An observational study of Metastatic Breast Cancer, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
The main aim of the study was to evaluate the real-world tolerability and safety of ribociclib as a first-line (1L) treatment among adults with hormone receptor-positive/human epidermal growth factor receptor-2 negative (HR+/HER2-) metastatic breast cancer (mBC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer
- How many people
- 373 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Apr 2024to 7 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This was a restrospective, noninterventional cohort study.
Who may be able to join
- Diagnosed with mBC on or after 1 January 2015.
- Had HR+/HER2- test results.
- Received ribociclib and endocrine therapy in 1L treatment.
- Patients had a gap of 90 days or less between mBC diagnosis date and the first structured EHR activity (e.g., lab tests and prescriptions) after metastatic diagnosis date.
Who cannot join
- None identified.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Real-world Outcomes Among Patients Treated With Kisqali (Ribociclib)
The main aim of the study was to evaluate the real-world tolerability and safety of ribociclib as a first-line (1L) treatment among adults with hormone receptor-positive/human epidermal growth factor receptor-2 negative (HR+/HER2-) metastatic breast cancer (mBC).
This study used data from the Flatiron Health Research Database (FHRD). The FHRD is a longitudinal database derived from electronic health records (EHRs) and other real-world data (RWD) sources from cancer care providers across the United States. The dataset generated for this study included de-identified patient-level data for eligible individuals between 1 January 2015 up to the data cutoff date, 30 November 2022.
- Conditions
- Metastatic Breast Cancer
- Keywords
- Hormone receptor-positive, Human epidermal growth factor receptor-2 negative, CDK4/6i, Real-world, Adverse Events
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ribociclib Cohort | Adult patients with mBC who received 1L treatment with ribociclib in combination with endocrine therapy (ET). | |
| Ribociclib Cohort: 65+ Years Age Group | Patients aged 65 years or older with mBC who received 1L treatment with ribociclib in combination with ET. | |
| Ribociclib Cohort: 75+ Years Age Group | Patients aged 75 years or older with mBC who received 1L treatment with ribociclib in combination with ET. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients by Type of Real-world Adverse Event (AE) of Interest During 1L Treatment
Measured: Up to approximately 5 years and 5 months
Number of Patients by Real-world AE of Interest at Baseline
Measured: Baseline
Number of Patients by Type of Real-world AE of Interest During 1L Treatment Among Those Without the Specific Real-world AE at Baseline
Measured: Up to approximately 5 years and 5 months
Secondary outcomes (23)
Number of Patients by Demographic Category
Demographics included:
- Age at start of 1L treatment (18-64, 65 years or older)
- Gender
- Race
- Ethnicity
Measured: Baseline
Number of Patients by Clinical Characteristic Category
Clinical characteristics included:
- Type of medical practice (academic, community or both)
- Geographic region
- Type of health plan
- Stage of cancer at initial diagnosis
- Year of metastatic cancer diagnosis
- Eastern Cooperative Oncology Group (ECOG) performance score
- Received chemotherapy prior to ribociclib treatment initiation
- Menopausal status
ECOG performance score measures a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability. Scores range from 0 (fully active, able to carry out all pre-disease performance without restriction) to 5 (deceased).
Measured: Baseline
Clinical Characteristic: Body Mass Index (BMI)
Measured: Baseline
Clinical Characteristic: Time Between Initial Diagnosis and Metastatic Diagnosis
Measured: Baseline
Clinical Characteristic: Time Between Metastatic Diagnosis and Initiation of 1L Treatment
Measured: Baseline
Clinical Characteristic: Duration of Follow-up
Measured: Up to approximately 5 years and 5 months
Clinical Characteristic: Number of Patients by Patient Disposition at Data Cutoff
Patient disposition included patients who died and discontinued treatment early.
Measured: Up to approximately 5 years and 5 months
Number of Patients by Year of Treatment Initiation for Each Line of Treatment
Lines of treatment included 1L, second-line (2L), and third-line (3L).
Measured: Up to approximately 5 years and 5 months
Duration of Each Line of Treatment
Lines of treatment included 1L, 2L, and 3L.
Measured: Up to approximately 5 years and 5 months
Number of Patients Still on 1L Treatment at Last EHR Activity
Measured: Up to approximately 5 years and 5 months
Number of Patients Still on 2L Treatment at Last EHR Activity
Measured: Up to approximately 5 years and 5 months
Number of Patients Still on 3L Treatment at Last EHR Activity
Measured: Up to approximately 5 years and 5 months
Number of Patients by Type of ET Partner During 1L Treatment
Measured: Up to approximately 5 years and 5 months
Number of Patients by Treatment Category During Each Line of Treatment
Lines of treatment included 1L, 2L, and 3L.
Treatment categories included:
- Cyclin dependent kinase 4/6 (CDK4/6) inhibitor based regimen
- Chemotherapy based regimen
- Clinical study drug
- ET monotherapy
- mTor based regimen
- PI3K based regimen
Measured: Up to approximately 5 years and 5 months
Number of Patients by Type of CDK4/6 Inhibitor Based Treatment During Each Line of Treatment
Lines of treatment included 1L, 2L, and 3L.
CDK4/6 inhibitor-based treatments included:
- Ribociclib
- Abemaciclib
- Palbociclib
Measured: Up to approximately 5 years and 5 months
Number of Patients by Total Number of Ribocicilib Dose Reduction Episodes During 1L Treatment
Measured: Up to approximately 5 years and 5 months
Number of Patients by Ribociclib Dose at Each Dose Reduction Episode During 1L Treatment
Measured: Up to approximately 5 years and 5 months
Number of Patients by Ribociclib Dosing Schedule at Each Dose Reduction Episode During 1L Treatment
Measured: Up to approximately 5 years and 5 months
Number of Patients by Status of Oral Therapy at the End of Each Dose Reduction Episode During 1L Treatment
Status included continuing, discontinued, dose change, held, not documented, and unknown, patient sent to hospice.
Measured: Up to approximately 5 years and 5 months
Number of Patients by Reason for Change in Ribociclib Dose During 1L Treatment
Measured: Up to approximately 5 years and 5 months
Number of Patients by Reason for Stopping Ribociclib 1L Treatment
Measured: Up to approximately 5 years and 5 months
Number of Patients by Type of Real-world Adverse Event (AE) During 1L Treatment
Measured: Up to approximately 5 years and 5 months
Number of Patients by Action Following or in Response to Real-world AE During 1L Treatment
Actions included:
- Hospitalization
- Treatment for AE
- Therapy discontinuation
- Therapy dose or schedule change
- Therapy hold
Measured: Up to approximately 5 years and 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start24 Apr 2024
- Primary completion7 Nov 2024
- Study completion7 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 373 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07148505
- Sponsor's protocol ID
- CLEE011AUS73
- Status last verified
- Aug 2025
- First submitted
- 21 Aug 2025
- Last updated
- 29 Aug 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Real-world Outcomes Among Patients Treated With Kisqali (Ribociclib)
- ClinicalTrials.gov ID
- NCT07148505
- Acronym / sponsor ID
- CLEE011AUS73
- Conditions
- Metastatic Breast Cancer
- Keywords
- Hormone receptor-positive, Human epidermal growth factor receptor-2 negative, CDK4/6i, Real-world, Adverse Events
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 373 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 24 Apr 2024 (actual)
- Primary completion
- 7 Nov 2024 (actual)
- Study completion
- 7 Nov 2024 (actual)
- First posted
- 29 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main aim of the study was to evaluate the real-world tolerability and safety of ribociclib as a first-line (1L) treatment among adults with hormone receptor-positive/human epidermal growth factor receptor-2 negative (HR+/HER2-) metastatic breast cancer (mBC).
This study used data from the Flatiron Health Research Database (FHRD). The FHRD is a longitudinal database derived from electronic health records (EHRs) and other real-world data (RWD) sources from cancer care providers across the United States. The dataset generated for this study included de-identified patient-level data for eligible individuals between 1 January 2015 up to the data cutoff date, 30 November 2022.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ribociclib Cohort | – | –Adult patients with mBC who received 1L treatment with ribociclib in combination with endocrine therapy (ET). |
| Ribociclib Cohort: 65+ Years Age Group | – | –Patients aged 65 years or older with mBC who received 1L treatment with ribociclib in combination with ET. |
| Ribociclib Cohort: 75+ Years Age Group | – | –Patients aged 75 years or older with mBC who received 1L treatment with ribociclib in combination with ET. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This was a restrospective, noninterventional cohort study.
Key inclusion criteria (4 listed)
- Diagnosed with mBC on or after 1 January 2015.
- Had HR+/HER2- test results.
- Received ribociclib and endocrine therapy in 1L treatment.
- Patients had a gap of 90 days or less between mBC diagnosis date and the first structured EHR activity (e.g., lab tests and prescriptions) after metastatic diagnosis date.
Key exclusion criteria (1 listed)
- None identified.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Patients by Type of Real-world Adverse Event (AE) of Interest During 1L Treatment
Time frame: Up to approximately 5 years and 5 months
Number of Patients by Real-world AE of Interest at Baseline
Time frame: Baseline
Number of Patients by Type of Real-world AE of Interest During 1L Treatment Among Those Without the Specific Real-world AE at Baseline
Time frame: Up to approximately 5 years and 5 months
23 secondary outcomes
Number of Patients by Demographic Category
Time frame: Baseline
Number of Patients by Clinical Characteristic Category
Time frame: Baseline
Clinical Characteristic: Body Mass Index (BMI)
Time frame: Baseline
Clinical Characteristic: Time Between Initial Diagnosis and Metastatic Diagnosis
Time frame: Baseline
Clinical Characteristic: Time Between Metastatic Diagnosis and Initiation of 1L Treatment
Time frame: Baseline
Clinical Characteristic: Duration of Follow-up
Time frame: Up to approximately 5 years and 5 months
Clinical Characteristic: Number of Patients by Patient Disposition at Data Cutoff
Time frame: Up to approximately 5 years and 5 months
Number of Patients by Year of Treatment Initiation for Each Line of Treatment
Time frame: Up to approximately 5 years and 5 months
Duration of Each Line of Treatment
Time frame: Up to approximately 5 years and 5 months
Number of Patients Still on 1L Treatment at Last EHR Activity
Time frame: Up to approximately 5 years and 5 months
Number of Patients Still on 2L Treatment at Last EHR Activity
Time frame: Up to approximately 5 years and 5 months
Number of Patients Still on 3L Treatment at Last EHR Activity
Time frame: Up to approximately 5 years and 5 months
Number of Patients by Type of ET Partner During 1L Treatment
Time frame: Up to approximately 5 years and 5 months
Number of Patients by Treatment Category During Each Line of Treatment
Time frame: Up to approximately 5 years and 5 months
Number of Patients by Type of CDK4/6 Inhibitor Based Treatment During Each Line of Treatment
Time frame: Up to approximately 5 years and 5 months
Number of Patients by Total Number of Ribocicilib Dose Reduction Episodes During 1L Treatment
Time frame: Up to approximately 5 years and 5 months
Number of Patients by Ribociclib Dose at Each Dose Reduction Episode During 1L Treatment
Time frame: Up to approximately 5 years and 5 months
Number of Patients by Ribociclib Dosing Schedule at Each Dose Reduction Episode During 1L Treatment
Time frame: Up to approximately 5 years and 5 months
Number of Patients by Status of Oral Therapy at the End of Each Dose Reduction Episode During 1L Treatment
Time frame: Up to approximately 5 years and 5 months
Number of Patients by Reason for Change in Ribociclib Dose During 1L Treatment
Time frame: Up to approximately 5 years and 5 months
Number of Patients by Reason for Stopping Ribociclib 1L Treatment
Time frame: Up to approximately 5 years and 5 months
Number of Patients by Type of Real-world Adverse Event (AE) During 1L Treatment
Time frame: Up to approximately 5 years and 5 months
Number of Patients by Action Following or in Response to Real-world AE During 1L Treatment
Time frame: Up to approximately 5 years and 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
Related trials for Metastatic Breast Cancer
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruiting
Augmented-Reality ICG Fluorescence Second-Look for Residual Nodal Disease After Axillary Dissection in Breast Cancer
Breast Cancer, Breast Neoplasms
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
RecruitingPhase 1/2
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Metastatic Breast Cancer
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Breast Cancer, run by Novartis Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients by Type of Real-world Adverse Event (AE) of Interest During 1L Treatment (time frame: Up to approximately 5 years and 5 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2025.