Breast CancerNCT07512063
A Study of Real-World Treatment Patterns and Outcomes Among HR+/HER2- Metastatic Breast Cancer Patients Treated With First-Line CDK4/6 Inhibitors
An observational study of Breast Cancer, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
The aim of this study was to evaluate patient profiles, treatment patterns, and outcomes of hormone receptor positive (HR+)/human epidermal growth factor receptor-2 negative (HER2-) metastatic breast cancer (mBC) patients treated with a 1L cyclin dependent kinase 4/6 inhibitor (CDK4/6i) in the real-world setting. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 480 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2024to 17 Mar 2025
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: HR+/HER2- mBC patients who received 1L CDK4/6i treatment and have a medical record in the real-world evidence database.
Who may be able to join
- A diagnosis of mBC based on at least two diagnoses of breast cancer (International Classification of Diseases, 10th Revision, Clinical Modification [ICD-10-CM] code C50.xxx) along with a diagnosis of secondary malignant neoplasm (ICD-10-CM codes C77.xxx - C80.xxx except C79.8 or C79.81, reporting of a metastatic site by curation), in the period prior to or on the index date.
- Patients with HR+/HER2- status.
- Use of either ribociclib, palbociclib, or abemaciclib in 1L treatment for mBC.
- Continuous care at the contributing practices. Patients with a minimum of two visits up to and including the index date.
Who cannot join
- Use of any prior CDK4/6i before the index date.
- Prior 1L treatment, other than CDK4/6i, in mBC including treatment with endocrine therapy (ET) either with tamoxifen, aromatase inhibitors (AI; anastrozole, exemestane, or letrozole) or fulvestrant. For it to be considered 1L in mBC, the diagnosis of mBC must have preceded treatment initiation, or was indicated so in unstructured data.
- Diagnosis of cancer other than breast cancer and/or mBC on or prior to the index.
- Evidence of participation in a clinical trial at any time during the study observation period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real World Treatment Patterns and Outcomes in HR+, HER2- Metastatic Breast Cancer Patients Treated With CDK 4/6 Inhibition in the First Line (1L) Setting
The aim of this study was to evaluate patient profiles, treatment patterns, and outcomes of hormone receptor positive (HR+)/human epidermal growth factor receptor-2 negative (HER2-) metastatic breast cancer (mBC) patients treated with a 1L cyclin dependent kinase 4/6 inhibitor (CDK4/6i) in the real-world setting.
- Conditions
- Breast Cancer
- Keywords
- Ribociclib, CDK4/6i, Metastatic breast cancer
- 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 |
|---|---|---|
| CDK4/6i Cohort | Adult HR+/HER2- mBC patients treated with 1L ribociclib, palbociclib, or abemaciclib. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and Percentage of Patients Treated With 1L Ribociclib by Demographic Category
Demographics included:
- Age group
- Sex
- Race
- Ethnicity
- Geographical region
- Payer type
- Year of 1L treatment initiation
- De novo or recurrent mBC
Measured: Baseline
Age at 1L Ribociclib Treatment Initiation
Measured: Baseline
Among 1L Ribociclib Patients, Age at mBC Diagnosis
Measured: Baseline
Among 1L Ribociclib Patients, Age at Initial BC Diagnosis
Measured: Baseline
Interval Between mBC Diagnosis and 1L Ribociclib Initiation
Measured: Baseline
Number and Percentage of 1L Ribociclib Patients by Clinical Characteristic Category
Clinical characteristics included:
- Menopausal status
- Eastern Cooperative Oncology Group (ECOG) performance status
- Stage at initial breast cancer (BC) diagnosis
- Comorbidities
- QT prolongation diagnosis (yes/no)
- Sites of metastasis
Measured: Baseline
Among 1L Ribociclib Patients, Body Mass Index (BMI)
Measured: Baseline
Follow-up Time From 1L Ribociclib Treatment Initiation
Measured: Up to approximately 7 years and 6 months
Among 1L Ribociclib Patients, Number of Metastatic Sites per Patient at Baseline
Measured: Baseline
Among 1L Ribociclib Patients, Number of Metastatic Sites per Patient any Time During Study
Measured: Up to approximately 7 years and 6 months
Number and Percentage of 1L Ribociclib Patients by Sites of Metastasis During Follow-up
Measured: Up to approximately 7 years and 6 months
Number and Percentage of 1L Ribociclib Patients by Type of Medical Procedures Received
Measured: Baseline
Number and Percentage of 1L Ribociclib Patients With ESR1 Mutation at Baseline
Measured: Baseline
Number and Percentage of 1L Ribociclib Patients With ESR1 Mutation any Time During Study
Measured: Up to approximately 7 years and 6 months
Among 1L Ribociclib Patients, Red Blood Cell (RBC) Count
Measured: Baseline
Among 1L Ribociclib Patients, Hemoglobin Level
Measured: Baseline
Among 1L Ribociclib Patients, Hematocrit Level
Measured: Baseline
Among 1L Ribociclib Patients, White Blood Cell Count
Measured: Baseline
Among 1L Ribociclib Patients, Platelet Count
Measured: Baseline
Number and Percentage of 1L Ribociclib Patients With Neutropenia
Measured: Baseline
Among 1L Ribociclib Patients, Serum Creatinine Level
Measured: Baseline
Among 1L Ribociclib Patients, Aspartate Aminotransferase (AST) Level
Measured: Baseline
Among 1L Ribociclib Patients, Alanine Aminotransferase (ALT) Level
Measured: Baseline
Among 1L Ribociclib Patients, Alkaline Phosphatase (ALP) Level
Measured: Baseline
Among 1L Ribociclib Patients, Bilirubin Level
Measured: Baseline
Number and Percentage of 1L Ribociclib Patients by Type of Other Medications in 1L Treatment
Measured: Baseline
Interval Between Treatment Initiation and Ribociclib Initiation
Measured: Baseline
Number and Percentage of Patients by Type of Treatment Received per Line of Treatment
Measured: Up to approximately 7 years and 6 months
Secondary outcomes (7)
Number and Percentage of 1L Ribociclib Patients by Type of First Dose Adjustment
Dose adjustments included up titration and down titration.
Measured: Up to approximately 7 years and 6 months
Among 1L Ribociclib Patients, Number of Total Dose Adjustments
Measured: Up to approximately 7 years and 6 months
Number and Percentage of 1L Ribociclib Patients by Starting Dose of Ribociclib
Measured: Baseline
Relative Dose Intensity (RDI) of Ribociclib
RDI was calculated by dividing the actual average daily dose by the recommended daily dose.
Measured: Up to approximately 7 years and 6 months
Ribociclib Dose at First Dose Adjustment
Measured: Up to approximately 7 years and 6 months
Among 1L Ribociclib Patients, Time to First Dose Adjustment
Measured: Up to approximately 7 years and 6 months
Number and Percentage of Patients by Ribociclib Dosage Received per Dose Adjustment
Measured: Up to approximately 7 years and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start8 Oct 2024
- Primary completion17 Mar 2025
- Study completion17 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 480 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
- NCT07512063
- Sponsor's protocol ID
- CLEE011AUS74
- Status last verified
- Mar 2026
- First submitted
- 12 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Treatment Patterns and Outcomes in HR+, HER2- Metastatic Breast Cancer Patients Treated With CDK 4/6 Inhibition in the First Line (1L) Setting
- ClinicalTrials.gov ID
- NCT07512063
- Acronym / sponsor ID
- CLEE011AUS74
- Conditions
- Breast Cancer
- Keywords
- Ribociclib, CDK4/6i, Metastatic breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 8 Oct 2024 (actual)
- Primary completion
- 17 Mar 2025 (actual)
- Study completion
- 17 Mar 2025 (actual)
- First posted
- 6 Apr 2026 (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 aim of this study was to evaluate patient profiles, treatment patterns, and outcomes of hormone receptor positive (HR+)/human epidermal growth factor receptor-2 negative (HER2-) metastatic breast cancer (mBC) patients treated with a 1L cyclin dependent kinase 4/6 inhibitor (CDK4/6i) in the real-world setting.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CDK4/6i Cohort | – | –Adult HR+/HER2- mBC patients treated with 1L ribociclib, palbociclib, or abemaciclib. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HR+/HER2- mBC patients who received 1L CDK4/6i treatment and have a medical record in the real-world evidence database.
Key inclusion criteria (4 listed)
- A diagnosis of mBC based on at least two diagnoses of breast cancer (International Classification of Diseases, 10th Revision, Clinical Modification [ICD-10-CM] code C50.xxx) along with a diagnosis of secondary malignant neoplasm (ICD-10-CM codes C77.xxx - C80.xxx except C79.8 or C79.81, reporting of a metastatic site by curation), in the period prior to or on the index date.
- Patients with HR+/HER2- status.
- Use of either ribociclib, palbociclib, or abemaciclib in 1L treatment for mBC.
- Continuous care at the contributing practices. Patients with a minimum of two visits up to and including the index date.
Key exclusion criteria (4 listed)
- Use of any prior CDK4/6i before the index date.
- Prior 1L treatment, other than CDK4/6i, in mBC including treatment with endocrine therapy (ET) either with tamoxifen, aromatase inhibitors (AI; anastrozole, exemestane, or letrozole) or fulvestrant. For it to be considered 1L in mBC, the diagnosis of mBC must have preceded treatment initiation, or was indicated so in unstructured data.
- Diagnosis of cancer other than breast cancer and/or mBC on or prior to the index.
- Evidence of participation in a clinical trial at any time during the study observation period.
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 and Percentage of Patients Treated With 1L Ribociclib by Demographic Category
Time frame: Baseline
Demographics included: * Age group * Sex * Race * Ethnicity * Geographical region * Payer type * Year of 1L treatment initiation * De novo or recurrent mBC
Age at 1L Ribociclib Treatment Initiation
Time frame: Baseline
Among 1L Ribociclib Patients, Age at mBC Diagnosis
Time frame: Baseline
Among 1L Ribociclib Patients, Age at Initial BC Diagnosis
Time frame: Baseline
Interval Between mBC Diagnosis and 1L Ribociclib Initiation
Time frame: Baseline
Number and Percentage of 1L Ribociclib Patients by Clinical Characteristic Category
Time frame: Baseline
Clinical characteristics included: * Menopausal status * Eastern Cooperative Oncology Group (ECOG) performance status * Stage at initial breast cancer (BC) diagnosis * Comorbidities * QT prolongation diagnosis (yes/no) * Sites of metastasis
Among 1L Ribociclib Patients, Body Mass Index (BMI)
Time frame: Baseline
Follow-up Time From 1L Ribociclib Treatment Initiation
Time frame: Up to approximately 7 years and 6 months
Among 1L Ribociclib Patients, Number of Metastatic Sites per Patient at Baseline
Time frame: Baseline
Among 1L Ribociclib Patients, Number of Metastatic Sites per Patient any Time During Study
Time frame: Up to approximately 7 years and 6 months
Number and Percentage of 1L Ribociclib Patients by Sites of Metastasis During Follow-up
Time frame: Up to approximately 7 years and 6 months
Number and Percentage of 1L Ribociclib Patients by Type of Medical Procedures Received
Time frame: Baseline
Number and Percentage of 1L Ribociclib Patients With ESR1 Mutation at Baseline
Time frame: Baseline
Number and Percentage of 1L Ribociclib Patients With ESR1 Mutation any Time During Study
Time frame: Up to approximately 7 years and 6 months
Among 1L Ribociclib Patients, Red Blood Cell (RBC) Count
Time frame: Baseline
Among 1L Ribociclib Patients, Hemoglobin Level
Time frame: Baseline
Among 1L Ribociclib Patients, Hematocrit Level
Time frame: Baseline
Among 1L Ribociclib Patients, White Blood Cell Count
Time frame: Baseline
Among 1L Ribociclib Patients, Platelet Count
Time frame: Baseline
Number and Percentage of 1L Ribociclib Patients With Neutropenia
Time frame: Baseline
Among 1L Ribociclib Patients, Serum Creatinine Level
Time frame: Baseline
Among 1L Ribociclib Patients, Aspartate Aminotransferase (AST) Level
Time frame: Baseline
Among 1L Ribociclib Patients, Alanine Aminotransferase (ALT) Level
Time frame: Baseline
Among 1L Ribociclib Patients, Alkaline Phosphatase (ALP) Level
Time frame: Baseline
Among 1L Ribociclib Patients, Bilirubin Level
Time frame: Baseline
Number and Percentage of 1L Ribociclib Patients by Type of Other Medications in 1L Treatment
Time frame: Baseline
Interval Between Treatment Initiation and Ribociclib Initiation
Time frame: Baseline
Number and Percentage of Patients by Type of Treatment Received per Line of Treatment
Time frame: Up to approximately 7 years and 6 months
7 secondary outcomes
Number and Percentage of 1L Ribociclib Patients by Type of First Dose Adjustment
Time frame: Up to approximately 7 years and 6 months
Among 1L Ribociclib Patients, Number of Total Dose Adjustments
Time frame: Up to approximately 7 years and 6 months
Number and Percentage of 1L Ribociclib Patients by Starting Dose of Ribociclib
Time frame: Baseline
Relative Dose Intensity (RDI) of Ribociclib
Time frame: Up to approximately 7 years and 6 months
Ribociclib Dose at First Dose Adjustment
Time frame: Up to approximately 7 years and 6 months
Among 1L Ribociclib Patients, Time to First Dose Adjustment
Time frame: Up to approximately 7 years and 6 months
Number and Percentage of Patients by Ribociclib Dosage Received per Dose Adjustment
Time frame: Up to approximately 7 years and 6 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 13 Apr 2026.
- Link to study resultsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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 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 4 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 13 Apr 2026. 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 and Percentage of Patients Treated With 1L Ribociclib by Demographic Category (time frame: Baseline). The study lists 28 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 13 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.