Metastatic Breast CancerNCT05141240
A Real-world Analysis of Concomitant Medication Use Among Metastatic Breast Cancer Patients Treated With CDK4/6 Inhibitors
An observational study of Metastatic Breast Cancer, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
This is a retrospective cohort study to assess the real-world analysis of concomitant medication use among metastatic breast cancer patients treated with CDK4/6 inhibitors utilizing the US Optum research administrative claims database. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Ribiciclib, Palbociclib and Abemaciclib
- How many people
- 4,650 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2020to 15 Jun 2020
- 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 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Study analyses were conducted among adult women with HR+/HER2- mBC receiving ribociclib, palbociclib, or abemaciclib, regardless of the line of therapy. Patients were identified from the US Optum Claims Data.
Who may be able to join
- Treated with CDK4/6i from 2015-02-01 to 2019-06-30
- ≥2 claims with a BC diagnosis recorded ≥30 days apart from the index date
- ≥2 claims with an mBC diagnosis, with a time interval between the first BC diagnosis date and the first mBC diagnosis date no longer than 30 days
- Female patients aged ≥18 years
- Continuous health plan enrollment for ≥3 months prior to the index date and ≥3 months post-index date
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Novartis Investigational site
East Hanover, New Jersey, 07936
About this study
This is a retrospective cohort study to assess the real-world analysis of concomitant medication use among metastatic breast cancer patients treated with CDK4/6 inhibitors utilizing the US Optum research administrative claims database.
Read the detailed description
This is a retrospective cohort study utilizing the US Optum research administrative claims database. Adult female patients who had HR+/HER2- mBC were identified and included in the study. These patients were stratified into three cohorts based on the first CDK4/6i received (ribociclib, palbociclib, or abemaciclib).
- Study period: Period during which all relevant medical and pharmacy information in the database was retrieved
- Index event identification period: time frame during which index treatment was identified
- First CDK4/6i: the date on which patients initiated their first treatment after being diagnosed with HR+/HER2- mBC; this date was considered as the index date
- Baseline period: Time frame during which patient characteristics, prior mBC treatments, and concomitant treatments received by CDK4/6i-naïve patients were evaluated
- Follow-up period: time frame on and after the index date during which patients' treatments and dosing patterns were observed
Establishment of baseline period Health plan enrollment in the three months prior to the index treatment was included in the baseline period. Patient demographics, clinical characteristics, National Cancer Institute (NCI) comorbidity index, concomitant medication use that can potentially lead to a DDI, and other BC treatments prior to the index treatment were evaluated during this period.
Establishment of follow-up period Patients were observed for ≥3 months starting from the index date until the end of the study period or continuous enrollment or until the time when patients switched to another therapy (including another CDK4/6i), whichever came first. Dosing patterns for CDK4/6i were evaluated in the follow-up period. Analyses were conducted at key time points of 3, 6, and 12 months
- Conditions
- Metastatic Breast Cancer
- Being tested
- Ribiciclib, Palbociclib, Abemaciclib
- Keywords
- Concomitant medication,, drug-drug interaction,, CDK4/6 inihibitor,, HR+/HER2-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.
RibiciclibDrug
Participants who initiated CDK4/6i therapy
PalbociclibDrug
Participants who initiated CDK4/6i therapy
AbemaciclibDrug
Participants who initiated CDK4/6i therapy
| Study group | Role | What they receive |
|---|---|---|
| Ribociclib | Participants who initiated CDK4/6i therapy Receives: Drug: Ribiciclib | |
| Palbociclib | Participants who initiated CDK4/6i therapy Receives: Drug: Palbociclib | |
| Abemaciclib | Participants who initiated CDK4/6i therapy Receives: Drug: Abemaciclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with a prescription fill of ribociclib, palbociclib, or abemaciclib
Distribution of patients with a prescription fill of ribociclib, palbociclib, or abemaciclib at index treatment date will be present by frequency among all patients treated with CDK4/6
Measured: Index date (defined as the prescription fill for ribociclib, palbociclib, or abemaciclib for the first time)
Number of participants who took concomitant medications in baseline period, by drug name
Number of patients taking a concomitant medication/s during baseline period that can potentially lead to a drug-drug interactions (DDI) with a CDK4/6 inhibitor use with each CDK4/6 inhibitor in the follow-up period.
Measured: Baseline period (3 months)
Number of participants who took concomitant medications in follow-up period, by drug name
Number of patients taking a concomitant medication/s during baseline period that can potentially lead to a drug-drug interactions (DDI) with a CDK4/6 inhibitor use with each CDK4/6 inhibitor in the follow-up period.
Measured: From index date (defined as the prescription fill for ribociclib, palbociclib, or abemaciclib for the first time) to the end of follow-up period (12 months post index date)
Number of participants with no use of concomitant medications
Adherence to concomitant medications during the baseline period was reported
Measured: Baseline period (3 months)
Number of participants with proportion of days covered (PDC) >80%
Adherence to concomitant medication during the baseline period will be assessed using the proportion of days covered (PDC):
PDC = total days of filled or refilled concomitant Rx in baseline period / total number of days in baseline period
Measured: Baseline period (3 months)
Number of participants with proportion of days covered (PDC) ≤80%
Adherence to concomitant medication during the baseline period will be assessed using the proportion of days covered (PDC):
PDC = total days of filled or refilled concomitant Rx in baseline period / total number of days in baseline period
Measured: Baseline period (3 months)
Number of other breast cancer medications used
Number of other breast cancer medications used in baseline period, by drug class (HR+/Endocrine, Chemotherapy, Other treatments), for breast cancer regimens was reported
Measured: Baseline period (3 months)
Secondary outcomes (6)
Mean starting dose for each CDK4/6
Distribution of starting dose and mean starting dose for each CDK4/6 was reported to describe dosing and treatment patterns associated with ribociclib, palbociclib, and abemaciclib patients
Measured: From index date (defined as the prescription fill for ribociclib, palbociclib, or abemaciclib for the first time) to the end of follow-up period (12 months post index date)
Number of participants who had any dose change (increase, decrease)
Number of patients with change in dose by each CDK4/6 inhibitor (ribociclib, palbociclib, and abemaciclib) in the follow-up period was reported
Measured: From index date (defined as the prescription fill for ribociclib, palbociclib, or abemaciclib for the first time) to the end of follow-up period (12 months post index date)
Number of participants who had a dose increase
Number of patients with change in dose by each CDK4/6 inhibitor (ribociclib, palbociclib, and abemaciclib) in the follow-up period was reported
Measured: From index date (defined as the prescription fill for ribociclib, palbociclib, or abemaciclib for the first time) to the end of follow-up period (12 months post index date)
Number of participants who had a dose decrease
Number of patients with change in dose by each CDK4/6 inhibitor (ribociclib, palbociclib, and abemaciclib) in the follow-up period was reported
Measured: From index date (defined as the prescription fill for ribociclib, palbociclib, or abemaciclib for the first time) to the end of follow-up period (12 months post index date)
Number of participants discontinuing each CDK4/6i (ribociclib, palbociclib, or abemaciclib)
Rate of discontinuation of ribociclib, palbociclib, or abemaciclib in the follow-up period was reported
Measured: From index date (defined as the prescription fill for ribociclib, palbociclib, or abemaciclib for the first time) to the end of follow-up period (12 months post index date)
Median duration of treatment (in months) by each CDK4/6i (ribociclib, palbociclib, or abemaciclib)
Duration of treatment with ribociclib, palbociclib, or abemaciclib, defined as discontinuation of each index CDK 4/6 treatment during the follow-up period was reported
Measured: From index date (defined as the prescription fill for ribociclib, palbociclib, or abemaciclib for the first time) to the end of follow-up period (12 months post index date)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start15 Apr 2020
- Primary completion15 Jun 2020
- Study completion15 Jun 2020
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
- 4,650 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
- NCT05141240
- Sponsor's protocol ID
- CLEE011AUS64
- Status last verified
- Dec 2021
- First submitted
- 11 Nov 2021
- Last updated
- 16 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real-world Analysis of Concomitant Medication Use Among Metastatic Breast Cancer Patients Treated With CDK4/6 Inhibitors
- ClinicalTrials.gov ID
- NCT05141240
- Acronym / sponsor ID
- CLEE011AUS64
- Conditions
- Metastatic Breast Cancer
- Keywords
- Concomitant medication,, drug-drug interaction,, CDK4/6 inihibitor,, HR+/HER2-metastatic breast cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,650 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- 15 Jun 2020 (actual)
- Study completion
- 15 Jun 2020 (actual)
- First posted
- 2 Dec 2021 (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.
This is a retrospective cohort study to assess the real-world analysis of concomitant medication use among metastatic breast cancer patients treated with CDK4/6 inhibitors utilizing the US Optum research administrative claims database.
Detailed description
This is a retrospective cohort study utilizing the US Optum research administrative claims database. Adult female patients who had HR+/HER2- mBC were identified and included in the study. These patients were stratified into three cohorts based on the first CDK4/6i received (ribociclib, palbociclib, or abemaciclib).
- Study period: Period during which all relevant medical and pharmacy information in the database was retrieved
- Index event identification period: time frame during which index treatment was identified
- First CDK4/6i: the date on which patients initiated their first treatment after being diagnosed with HR+/HER2- mBC; this date was considered as the index date
- Baseline period: Time frame during which patient characteristics, prior mBC treatments, and concomitant treatments received by CDK4/6i-naïve patients were evaluated
- Follow-up period: time frame on and after the index date during which patients' treatments and dosing patterns were observed
Establishment of baseline period Health plan enrollment in the three months prior to the index treatment was included in the baseline period. Patient demographics, clinical characteristics, National Cancer Institute (NCI) comorbidity index, concomitant medication use that can potentially lead to a DDI, and other BC treatments prior to the index treatment were evaluated during this period.
Establishment of follow-up period Patients were observed for ≥3 months starting from the index date until the end of the study period or continuous enrollment or until the time when patients switched to another therapy (including another CDK4/6i), whichever came first. Dosing patterns for CDK4/6i were evaluated in the follow-up period. Analyses were conducted at key time points of 3, 6, and 12 months
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ribociclib | – | Drug: RibiciclibParticipants who initiated CDK4/6i therapy |
| Palbociclib | – | Drug: PalbociclibParticipants who initiated CDK4/6i therapy |
| Abemaciclib | – | Drug: AbemaciclibParticipants who initiated CDK4/6i therapy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study analyses were conducted among adult women with HR+/HER2- mBC receiving ribociclib, palbociclib, or abemaciclib, regardless of the line of therapy. Patients were identified from the US Optum Claims Data.
Key inclusion criteria (5 listed)
- Treated with CDK4/6i from 2015-02-01 to 2019-06-30
- ≥2 claims with a BC diagnosis recorded ≥30 days apart from the index date
- ≥2 claims with an mBC diagnosis, with a time interval between the first BC diagnosis date and the first mBC diagnosis date no longer than 30 days
- Female patients aged ≥18 years
- Continuous health plan enrollment for ≥3 months prior to the index date and ≥3 months post-index date
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RibiciclibParticipants who initiated CDK4/6i therapy | Drug | Ribociclib |
| PalbociclibParticipants who initiated CDK4/6i therapy | Drug | Palbociclib |
| AbemaciclibParticipants who initiated CDK4/6i therapy | Drug | Abemaciclib |
Primary outcome
Number of participants with a prescription fill of ribociclib, palbociclib, or abemaciclib
Time frame: Index date (defined as the prescription fill for ribociclib, palbociclib, or abemaciclib for the first time)
Distribution of patients with a prescription fill of ribociclib, palbociclib, or abemaciclib at index treatment date will be present by frequency among all patients treated with CDK4/6
Number of participants who took concomitant medications in baseline period, by drug name
Time frame: Baseline period (3 months)
Number of patients taking a concomitant medication/s during baseline period that can potentially lead to a drug-drug interactions (DDI) with a CDK4/6 inhibitor use with each CDK4/6 inhibitor in the follow-up period.
Number of participants who took concomitant medications in follow-up period, by drug name
Time frame: From index date (defined as the prescription fill for ribociclib, palbociclib, or abemaciclib for the first time) to the end of follow-up period (12 months post index date)
Number of patients taking a concomitant medication/s during baseline period that can potentially lead to a drug-drug interactions (DDI) with a CDK4/6 inhibitor use with each CDK4/6 inhibitor in the follow-up period.
Number of participants with no use of concomitant medications
Time frame: Baseline period (3 months)
Adherence to concomitant medications during the baseline period was reported
Number of participants with proportion of days covered (PDC) >80%
Time frame: Baseline period (3 months)
Adherence to concomitant medication during the baseline period will be assessed using the proportion of days covered (PDC): PDC = total days of filled or refilled concomitant Rx in baseline period / total number of days in baseline period
Number of participants with proportion of days covered (PDC) ≤80%
Time frame: Baseline period (3 months)
Adherence to concomitant medication during the baseline period will be assessed using the proportion of days covered (PDC): PDC = total days of filled or refilled concomitant Rx in baseline period / total number of days in baseline period
Number of other breast cancer medications used
Time frame: Baseline period (3 months)
Number of other breast cancer medications used in baseline period, by drug class (HR+/Endocrine, Chemotherapy, Other treatments), for breast cancer regimens was reported
6 secondary outcomes
Mean starting dose for each CDK4/6
Time frame: From index date (defined as the prescription fill for ribociclib, palbociclib, or abemaciclib for the first time) to the end of follow-up period (12 months post index date)
Number of participants who had any dose change (increase, decrease)
Time frame: From index date (defined as the prescription fill for ribociclib, palbociclib, or abemaciclib for the first time) to the end of follow-up period (12 months post index date)
Number of participants who had a dose increase
Time frame: From index date (defined as the prescription fill for ribociclib, palbociclib, or abemaciclib for the first time) to the end of follow-up period (12 months post index date)
Number of participants who had a dose decrease
Time frame: From index date (defined as the prescription fill for ribociclib, palbociclib, or abemaciclib for the first time) to the end of follow-up period (12 months post index date)
Number of participants discontinuing each CDK4/6i (ribociclib, palbociclib, or abemaciclib)
Time frame: From index date (defined as the prescription fill for ribociclib, palbociclib, or abemaciclib for the first time) to the end of follow-up period (12 months post index date)
Median duration of treatment (in months) by each CDK4/6i (ribociclib, palbociclib, or abemaciclib)
Time frame: From index date (defined as the prescription fill for ribociclib, palbociclib, or abemaciclib for the first time) to the end of follow-up period (12 months post index date)
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 16 Dec 2021.
- Results for CLEE011AUS64 from the Novartis Clinical Trials WebsiteLink provided by the sponsor.
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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 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 5 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 16 Dec 2021. 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 participants with a prescription fill of ribociclib, palbociclib, or abemaciclib (time frame: Index date (defined as the prescription fill for ribociclib, palbociclib, or abemaciclib for the first time)). The study lists 7 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 16 Dec 2021.