A Real-World Study of Treatment Patterns, Tolerability and Effectiveness of CDK4/6 Inhibition in HR+, HER2-negative Metastatic Breast Cancer Patients

An observational study of Breast Cancer, run by Novartis Pharmaceuticals at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 18 to 120 years
Conditions the study is for: Breast Cancer
How many people: 945 participants
Where: 1 siteUnited States
Study dates: 26 Feb 2025to 29 Aug 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 to 120 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: HR+/HER2- recurrent or mBC cancer patients aged 65 years or older, and who self-identify as African American, and initiated 1L ribociclib plus ET on or after January 01, 2018.

Who may be able to join

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

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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
Had 1L ribociclib on or before April 30, 2024, to allow for at least 6 months of potential follow-up time prior to the data cutoff date of October 31, 2024

Who cannot join

Use of any CDK4/6 inhibitor therapy in combination with tamoxifen
Use of any CDK4/6 inhibitor in the pre-metastatic setting

Trial locations and contacts

1 site in 1 country.

United States1 site

Novartis
East Hanover, New Jersey, 07936

Other trials in United States

About this study

Official title: Real-World, Retrospective Study of Treatment Patterns, Tolerability and Effectiveness of CDK4/6 Inhibition in HR+, HER2-negative Metastatic Breast Cancer, With a Focus on Patients 65 Years and Older, and Patients Who Self-identify as African American

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.

Conditions: Breast Cancer
Keywords: Ribociclib, CDK4/6 inhibitor, Metastatic breast cancer, HR+/HER2-, Real-world evidence, Treatment patterns, Dose modification, Tolerability, Older adults, African American
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 groups in NCT07760714
Study group	Role	What they receive
Adults Aged 65 and Older		HR+/HER2- mBC cancer patients aged 65 years or older who initiated 1L ribociclib plus ET on or after January 01, 2018.
Adults Aged 75 and Older		HR+/HER2- mBC cancer patients aged 75 years or older who initiated 1L ribociclib plus ET on or after January 01, 2018.
Black or African American Adults		HR+/HER2- mBC cancer patients aged 65 years or older who self-identify as Black/African American and initiated 1L ribociclib plus ET on or after January 01, 2018.

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Demographics and clinical characteristics included race/ethnicity, practice type, geographic region, insurance type, socioeconomic status (SES) quintile, stage at initial diagnosis, menopausal status at 1L start, sites of metastasis, endocrine sensitivity status, year of 1L initiation, and prior chemotherapy exposure.
Measured: Baseline
Age at 1L Ribociclib Initiation Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older
Measured: Baseline
Body Mass Index (BMI) at 1L Ribociclib Initiation Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older
Measured: Baseline
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,
ECOG performance status is a scale used to measure a patient's level of functioning in terms of self-care, 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
Duration Between Metastatic Diagnosis and 1L Ribociclib Initiation Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older
Measured: Baseline
Number of Patients by Initial and Subsequent Dosing Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older
Measured: Up to approximately 6 years, 10 months
Number of Patients With Dose Modifications Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older
Dose modifications defined as a dose being held, increased, or decreased.
Measured: Up to approximately 6 years, 10 months
Number of Patients by Reasons for Dose Modifications Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older
Dose modifications defined as a dose being held, increased, or decreased.
Measured: Up to approximately 6 years, 10 months
Number of Patients Who Discontinued Treatment Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older
Measured: Up to approximately 6 years, 10 months
Number of Patients by Reason for Treatment Discontinuation Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older
Measured: Up to approximately 6 years, 10 months

Secondary outcomes (10)

Number of Patients Who Initiated 1L Ribociclib Treatment for HR+/HER2- mBC, by Demographic and Clinical Characteristics Among Black/African American Patients
Demographics and clinical characteristics included race/ethnicity, practice type, geographic region, insurance type, socioeconomic status (SES) quintile, stage at initial diagnosis, menopausal status at 1L start, sites of metastasis, endocrine sensitivity status, year of 1L initiation, and prior chemotherapy exposure.
Measured: Baseline
Age at 1L Ribociclib Initiation Among Black/African American Patients
Measured: Baseline
BMI at 1L Ribociclib Initiation Among Black/African American Patients
Measured: Baseline
Number of Patients by ECOG Performance Status Among Black/African American Patients
ECOG performance status is a scale used to measure a patient's level of functioning in terms of self-care, 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
Duration Between Metastatic Diagnosis and 1L Ribociclib Initiation Among Black/African American Patients
Measured: Baseline
Number of Patients by Initial and Subsequent Dosing Among Black/African American Patients
Measured: Up to approximately 6 years, 10 months
Number of Patients With Dose Modifications Among Black/African American Patients
Dose modifications defined as a dose being held, increased, or decreased.
Measured: Up to approximately 6 years, 10 months
Number of Patients by Reasons for Dose Modifications Among Black/African American Patients
Dose modifications defined as a dose being held, increased, or decreased.
Measured: Up to approximately 6 years, 10 months
Number of Patients Who Discontinued Treatment Among Black/African American Patients
Measured: Up to approximately 6 years, 10 months
Number of Patients by Reason for Treatment Discontinuation Among Black/African American Patients
Measured: Up to approximately 6 years, 10 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Feb 202529 Aug 2025

First posted12 Aug 2026
Study start26 Feb 2025
Primary completion29 Aug 2025
Study completion29 Aug 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: 945 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07760714
Sponsor's protocol ID: CLEE011AUS70
Status last verified: Aug 2026
First submitted: 7 Aug 2026
Last updated: 14 Aug 2026
Results posted: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Real-World, Retrospective Study of Treatment Patterns, Tolerability and Effectiveness of CDK4/6 Inhibition in HR+, HER2-negative Metastatic Breast Cancer, With a Focus on Patients 65 Years and Older, and Patients Who Self-identify as African American
ClinicalTrials.gov ID: NCT07760714
Acronym / sponsor ID: CLEE011AUS70
Conditions: Breast Cancer
Keywords: Ribociclib, CDK4/6 inhibitor, Metastatic breast cancer, HR+/HER2-, Real-world evidence, Treatment patterns, Dose modification, Tolerability
Study type: Observational
Recruitment status: Completed
Enrolment: 945 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 26 Feb 2025 (actual)
Primary completion: 29 Aug 2025 (actual)
Study completion: 29 Aug 2025 (actual)
First posted: 12 Aug 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.

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 3

Arm	Type	Receives
Adults Aged 65 and Older	–	–HR+/HER2- mBC cancer patients aged 65 years or older who initiated 1L ribociclib plus ET on or after January 01, 2018.
Adults Aged 75 and Older	–	–HR+/HER2- mBC cancer patients aged 75 years or older who initiated 1L ribociclib plus ET on or after January 01, 2018.
Black or African American Adults	–	–HR+/HER2- mBC cancer patients aged 65 years or older who self-identify as Black/African American and initiated 1L ribociclib plus ET on or after January 01, 2018.

Who may qualify

Ages: 18 to 120 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: HR+/HER2- recurrent or mBC cancer patients aged 65 years or older, and who self-identify as African American, and initiated 1L ribociclib plus ET on or after January 01, 2018.

Key inclusion criteria (9 listed)

Included in Flatiron's mBC Enhanced Data Model (EDM):
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
Had 1L ribociclib on or before April 30, 2024, to allow for at least 6 months of potential follow-up time prior to the data cutoff date of October 31, 2024

Key exclusion criteria (2 listed)

Use of any CDK4/6 inhibitor therapy in combination with tamoxifen
Use of any CDK4/6 inhibitor in the pre-metastatic setting

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 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
Time frame: Baseline
Demographics and clinical characteristics included race/ethnicity, practice type, geographic region, insurance type, socioeconomic status (SES) quintile, stage at initial diagnosis, menopausal status at 1L start, sites of metastasis, endocrine sensitivity status, year of 1L initiation, and prior chemotherapy exposure.
Age at 1L Ribociclib Initiation Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older
Time frame: Baseline
Body Mass Index (BMI) at 1L Ribociclib Initiation Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older
Time frame: Baseline
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,
Time frame: Baseline
ECOG performance status is a scale used to measure a patient's level of functioning in terms of self-care, daily activity, and physical ability. Scores range from 0 (fully active, able to carry out all pre-disease performance without restriction) to 5 (deceased).
Duration Between Metastatic Diagnosis and 1L Ribociclib Initiation Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older
Time frame: Baseline
Number of Patients by Initial and Subsequent Dosing Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older
Time frame: Up to approximately 6 years, 10 months
Number of Patients With Dose Modifications Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older
Time frame: Up to approximately 6 years, 10 months
Dose modifications defined as a dose being held, increased, or decreased.
Number of Patients by Reasons for Dose Modifications Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older
Time frame: Up to approximately 6 years, 10 months
Dose modifications defined as a dose being held, increased, or decreased.
Number of Patients Who Discontinued Treatment Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older
Time frame: Up to approximately 6 years, 10 months
Number of Patients by Reason for Treatment Discontinuation Among Patients Aged 65 Years and Older, and Patients Aged 75 Years and Older
Time frame: Up to approximately 6 years, 10 months

10 secondary outcomes

Number of Patients Who Initiated 1L Ribociclib Treatment for HR+/HER2- mBC, by Demographic and Clinical Characteristics Among Black/African American Patients
Time frame: Baseline
Age at 1L Ribociclib Initiation Among Black/African American Patients
Time frame: Baseline
BMI at 1L Ribociclib Initiation Among Black/African American Patients
Time frame: Baseline
Number of Patients by ECOG Performance Status Among Black/African American Patients
Time frame: Baseline
Duration Between Metastatic Diagnosis and 1L Ribociclib Initiation Among Black/African American Patients
Time frame: Baseline
Number of Patients by Initial and Subsequent Dosing Among Black/African American Patients
Time frame: Up to approximately 6 years, 10 months
Number of Patients With Dose Modifications Among Black/African American Patients
Time frame: Up to approximately 6 years, 10 months
Number of Patients by Reasons for Dose Modifications Among Black/African American Patients
Time frame: Up to approximately 6 years, 10 months
Number of Patients Who Discontinued Treatment Among Black/African American Patients
Time frame: Up to approximately 6 years, 10 months
Number of Patients by Reason for Treatment Discontinuation Among Black/African American Patients
Time frame: Up to approximately 6 years, 10 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 14 Aug 2026.
Link to study resultsLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Breast Cancer

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Sarcopenia, Breast Cancer
RecruitingPhase 2
A Clinical Study on Prophylactic RespOnse To hEtrombopag for Secondary Prevention in Anti-Cancer Therapy-induced Thrombocytopeniae
Breast Cancer Patients at High Risk of Chemotherapy-induced Thrombocytopenia (CTIT)
Not yet recruitingPhase 2
Trastuzumab Deruxtecan and Lovastatin in HER2-low and Ultralow Advanced or Metastatic Breast Cancer
Breast Cancer, Advanced Breast Cancer
RecruitingObservational study
Audit of Targeted Sentinel Node Biopsy (TSNB) in Patients With Limited Nodal Disease Undergoing Primary Surgery
Breast Cancer, Axillary Lymph Nodes Dissection
RecruitingPhase 2
A Vaccine (STEMVAC) With Standard Endocrine-Based Therapy or Chemotherapy for the Treatment of Metastatic Hormone Receptor Positive, HER2 Negative Breast Cancer
Anatomic Stage IV Breast Cancer AJCC v8, Metastatic HER2-Negative 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 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 9 inclusion and 2 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 14 Aug 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 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 (time frame: Baseline). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07760714.

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 14 Aug 2026.