Metastatic HR+/HER2- Breast CancerNCT07086196
A Study of Real-World Outcomes of Ribociclib in First-Line Treatment for Metastatic HR+/HER2- Breast Cancer
An observational study of Metastatic HR+/HER2- Breast Cancer, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
The main aim of this study was to describe the profile of hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) metastatic breast cancer (mBC) patients who received first-line (1L) current treatment options with ribociclib in the United States (US) clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic HR+/HER2- Breast Cancer
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- 30 May 2024to 30 Aug 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 retrospective, non-interventional cohort study.
Who may be able to join
- Had 1 or more paid pharmacy claims for ribociclib with the first claim for the CDK4/6i observed between 26 February 2018 and 31 December 2022 (i.e., during the index period)
- With the index CDK4/6i used in combination with an endocrine-based therapy, that is an aromatase inhibitor (i.e., letrozole, anastrozole, or exemestane), or fulvestrant, as 1L treatment for mBC
- With the endocrine therapy (ET) initiated within 60 days of the first paid pharmacy claim of the index CDK4/6i; ET may have been initiated no earlier than 60 days prior to the index date (expected window for insurance approval of the CDK4/6i as 1L treatment for mBC in a real-world setting)
- Adult who was 18 years of age or older as of the index date
- Had 2 or more medical service claims with a code for breast cancer (BC) separated by 30 days or more, and 1 or more claims with a code for BC prior to the index date
- Had 2 or more medical service claims with a code for a secondary neoplasm separated by 30 days or more, with the first code for a secondary neoplasm occurring not earlier than 30 days from the first diagnosis for BC, and 1 or more claims with a code for a secondary neoplasm prior to the index date
- Had continuous health plan enrollment for 12 months or more prior to and 1 month or more after the index date
Who cannot join
- Patients who did not meet the inclusion criteria
- Had a diagnosis for other primary cancers (other than BC) before the first diagnosis for secondary neoplasm
- Had prior treatments for BC (i.e., chemotherapy, targeted therapy, ET [except ≤60 days prior to index date], or immunotherapy) during the 12-month washout period (relapsed/progressed ≤12 months prior to index date)
- Had prior surgical procedure for BC during the 12-month washout period (relapsed/progressed ≤12 months prior to index date)
- Had evidence of participation in a clinical trial prior to or at the index date (International Classification of Disease, 10th Edition, Clinical Modification [ICD-10-CM]: Z00.6)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Analysis of Real-World Outcomes of Ribociclib in First-Line Treatment for Metastatic HR+/HER2- Breast Cancer
The main aim of this study was to describe the profile of hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) metastatic breast cancer (mBC) patients who received first-line (1L) current treatment options with ribociclib in the United States (US) clinical practice.
This study used administrative claims data. De-identified patient-level data of adult patients with HR+/HER2- mBC who initiated 1L treatment with a cyclin dependant kinase 4/6 inhibitor (CDK4/6i) i.e., ribociclib from the Komodo Health Solutions Research Database (KRD; data from 1 January 2016 to 30 June 2023) was used. Data included medical and pharmacy claims for insured patients, which had already been collected (i.e., secondary use of data).
- Conditions
- Metastatic HR+/HER2- Breast Cancer
- Keywords
- Hormone receptor, Human epidermal growth factor receptor 2, Breast cancer, Administrative claims
- 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 | Patients who received ribociclib as 1L treatment for HR+/HER2- mBC. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number Patients by Demographic Category
Demographics included:
- Age (≥ 65 years, ≥ 75 years)
- Gender
- Race
- Index year (year of the first paid pharmacy claim for ribociclib)
Measured: Baseline
Number of Patients by Clinical Characteristic Category
Clinical characteristic categories included:
- Menopausal status
- Comorbidity
- Metastatic site
- Eastern Cooperative Oncology Group (ECOG) performance score less than 2
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: National Cancer Institute (NCI) Comorbidity Index Score
The NCI comorbidity index is a tool used to measure the risk of non-cancer deaths for cancer patients based on the presence and severity of other health conditions. It includes 14 conditions identified using administrative data diagnosis and procedure codes. The index excludes solid tumors, leukemias, and lymphomas as comorbid conditions. Each condition is assigned a score based on how serious it is and patient scores are summed to give a final overall score. A high score indicates a higher burden of comorbid conditions and possible higher risk of death.
Measured: Baseline
Clinical Characteristic: Number of Metastatic Sites
Measured: Baseline
Treatment Characteristic: Number of Patients by Type of Treatment Received While on 1L mBC Treatment
Treatments included:
- Endocrine therapy partner (AI, Fulvestrant, or AI and Fulvestrant)
- Gonadotropin-releasing hormone (GNRH)
- Cytochrome P450, family 3, subfamily A (CYP3A) inhibitors and inducers
- P-inhibitors and inducers
- Medications potentially associated with an increased risk of torsade de pointes
Measured: Up to approximately 3 years and 4 months
Treatment Characteristic: Time from mBC diagnosis to 1L Initiation
Measured: Baseline
Treatment Characteristic: Duration of Follow-up From 1L Initiation
Measured: Up to approximately 3 years and 4 months
Treatment Characteristic: Duration of 1L mBC Treatment
Measured: Up to approximately 3 years and 4 months
Secondary outcomes (2)
Number of Patients by Tolerability-related Medical Events Experienced While on 1L Treatment With Ribociclib
Medical events were assessed among patients who did not have the selected condition during the baseline period and were described based on the presence of 2 or more medical claims on distinct dates.
Measured: Up to approximately 3 years and 4 months
Number of Patients by Cardiovascular-related Medical Events Experienced While on 1L Treatment With Ribociclib
Medical events were assessed among patients who did not have the selected condition during the baseline period and were described based on the presence of 2 or more medical claims on distinct dates.
Measured: Up to approximately 3 years and 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start30 May 2024
- Primary completion30 Aug 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic HR+/HER2- 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
- 350 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
- NCT07086196
- Sponsor's protocol ID
- CLEE011AUS72
- Status last verified
- Jul 2025
- First submitted
- 17 Jul 2025
- Last updated
- 25 Jul 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of Real-World Outcomes of Ribociclib in First-Line Treatment for Metastatic HR+/HER2- Breast Cancer
- ClinicalTrials.gov ID
- NCT07086196
- Acronym / sponsor ID
- CLEE011AUS72
- Conditions
- Metastatic HR+/HER2- Breast Cancer
- Keywords
- Hormone receptor, Human epidermal growth factor receptor 2, Breast cancer, Administrative claims
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 30 May 2024 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 25 Jul 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 this study was to describe the profile of hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) metastatic breast cancer (mBC) patients who received first-line (1L) current treatment options with ribociclib in the United States (US) clinical practice.
This study used administrative claims data. De-identified patient-level data of adult patients with HR+/HER2- mBC who initiated 1L treatment with a cyclin dependant kinase 4/6 inhibitor (CDK4/6i) i.e., ribociclib from the Komodo Health Solutions Research Database (KRD; data from 1 January 2016 to 30 June 2023) was used. Data included medical and pharmacy claims for insured patients, which had already been collected (i.e., secondary use of data).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ribociclib Cohort | – | –Patients who received ribociclib as 1L treatment for HR+/HER2- mBC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This was a retrospective, non-interventional cohort study.
Key inclusion criteria (7 listed)
- Had 1 or more paid pharmacy claims for ribociclib with the first claim for the CDK4/6i observed between 26 February 2018 and 31 December 2022 (i.e., during the index period)
- Adult who was 18 years of age or older as of the index date
- Had 2 or more medical service claims with a code for breast cancer (BC) separated by 30 days or more, and 1 or more claims with a code for BC prior to the index date
- Had 2 or more medical service claims with a code for a secondary neoplasm separated by 30 days or more, with the first code for a secondary neoplasm occurring not earlier than 30 days from the first diagnosis for BC, and 1 or more claims with a code for a secondary neoplasm prior to the index date
- Had continuous health plan enrollment for 12 months or more prior to and 1 month or more after the index date
Key exclusion criteria (5 listed)
- Patients who did not meet the inclusion criteria
- Had a diagnosis for other primary cancers (other than BC) before the first diagnosis for secondary neoplasm
- Had prior treatments for BC (i.e., chemotherapy, targeted therapy, ET [except ≤60 days prior to index date], or immunotherapy) during the 12-month washout period (relapsed/progressed ≤12 months prior to index date)
- Had prior surgical procedure for BC during the 12-month washout period (relapsed/progressed ≤12 months prior to index date)
- Had evidence of participation in a clinical trial prior to or at the index date (International Classification of Disease, 10th Edition, Clinical Modification [ICD-10-CM]: Z00.6)
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 Patients by Demographic Category
Time frame: Baseline
Demographics included: * Age (≥ 65 years, ≥ 75 years) * Gender * Race * Index year (year of the first paid pharmacy claim for ribociclib)
Number of Patients by Clinical Characteristic Category
Time frame: Baseline
Clinical characteristic categories included: * Menopausal status * Comorbidity * Metastatic site * Eastern Cooperative Oncology Group (ECOG) performance score less than 2 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).
Clinical Characteristic: National Cancer Institute (NCI) Comorbidity Index Score
Time frame: Baseline
The NCI comorbidity index is a tool used to measure the risk of non-cancer deaths for cancer patients based on the presence and severity of other health conditions. It includes 14 conditions identified using administrative data diagnosis and procedure codes. The index excludes solid tumors, leukemias, and lymphomas as comorbid conditions. Each condition is assigned a score based on how serious it is and patient scores are summed to give a final overall score. A high score indicates a higher burden of comorbid conditions and possible higher risk of death.
Clinical Characteristic: Number of Metastatic Sites
Time frame: Baseline
Treatment Characteristic: Number of Patients by Type of Treatment Received While on 1L mBC Treatment
Time frame: Up to approximately 3 years and 4 months
Treatments included: * Endocrine therapy partner (AI, Fulvestrant, or AI and Fulvestrant) * Gonadotropin-releasing hormone (GNRH) * Cytochrome P450, family 3, subfamily A (CYP3A) inhibitors and inducers * P-inhibitors and inducers * Medications potentially associated with an increased risk of torsade de pointes
Treatment Characteristic: Time from mBC diagnosis to 1L Initiation
Time frame: Baseline
Treatment Characteristic: Duration of Follow-up From 1L Initiation
Time frame: Up to approximately 3 years and 4 months
Treatment Characteristic: Duration of 1L mBC Treatment
Time frame: Up to approximately 3 years and 4 months
2 secondary outcomes
Number of Patients by Tolerability-related Medical Events Experienced While on 1L Treatment With Ribociclib
Time frame: Up to approximately 3 years and 4 months
Number of Patients by Cardiovascular-related Medical Events Experienced While on 1L Treatment With Ribociclib
Time frame: Up to approximately 3 years and 4 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 25 Jul 2025.
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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 Metastatic HR+/HER2- 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 7 inclusion and 5 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 25 Jul 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 Patients by Demographic Category (time frame: Baseline). The study lists 8 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 25 Jul 2025.