Metastatic Breast CancerNCT05153135
Description of Treatment Patterns and Description and Comparison of Healthcare Resource Utilization and Costs of Women With Metastatic HR+/HER2- Breast Cancer Treated With CDK4/6 Inhibitors
An observational study of Metastatic Breast Cancer, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
The study was an observational, retrospective cohort design, using US administrative insurance claims data, to better understand Healthcare resource utilization (HRU) and healthcare costs among women with mBC initiated on a CDK4/6 inhibitor. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Ribociclib, Palbociclib and Abemaciclib
- How many people
- 4,320 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2020to 31 Jul 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 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Study analyses were conducted among HR+/HER2- women with at least one claim for treatment with CDK4/6 inhibitor for mBC
Who may be able to join
- Evidence of treatment with a CDK4/6 inhibitor regardless of the line of therapy.
- The initiation of the first CDK4/6 inhibitor was defined as the index date, and the first CDK4/6 inhibitor initiated was defined as the index treatment
- BC diagnosis: Two diagnosis codes of BC (International Classification of Diseases, 9th Revision, Clinical Modification [ICD-9-CM]: 174.xx and International Classification of Diseases, 10th Revision, Clinical Modification [ICD-10-CM]: C50.xx [excluding C50.x2 - male BC]) on two medical service claims separated by at least 30 days
- Metastatic disease diagnosis: At least two medical claims for a secondary neoplasm (ICD-9-CM codes: 196.xx-197.xx, 198.xx, ICD-10-CM codes: C77.xx, C78.xx, C79.xx) on separate dates, with the first one occurring no more than 30 days before the first diagnosis for BC
- HR+/HER2-: At least one prescription fill or administration of an ET (anastrazole, exemestane, ethinyl estradiol, fulvestrant, fluoxymesterone, letrozole, megestrol acetate, tamoxifen, or toremifene), HR+/HER2- therapy (everolimus), or CDK4/6 inhibitor (i.e., abemaciclib, palbociclib, or ribociclib) at any time following the diagnosis of BC, and no claims for treatments indicated for HER2+ BC, including trastuzumab, lapatinib, afatinib, pertuzumab, or ado-trastuzumab, at any time in the data period
- Women of at least 18 years of age as of the index date
- At least 6 months of continuous health plan coverage prior to and at least 1 month of continuous health plan coverage after the index date
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Novartis Investigative Site
East Hanover, New Jersey, 07936
About this study
The study was an observational, retrospective cohort design, using US administrative insurance claims data, to better understand Healthcare resource utilization (HRU) and healthcare costs among women with mBC initiated on a CDK4/6 inhibitor.
Read the detailed description
This study used an observational, retrospective cohort design, using US administrative insurance claims data, previously employed in an existing project, to better understand HRU and healthcare costs among women with mBC initiated on a CDK4/6 inhibitor.
Adult women with HR+/HER2- mBC initiated on a CDK4/6 inhibitor were included in the study and were stratified into cohorts based on the first CDK4/6 inhibitor they received (i.e., abemaciclib, palbociclib, or ribociclib), regardless of the line of therapy and menopausal status.
The initiation of the first CDK4/6 inhibitor was defined as the index date. The index treatment was defined as the CDK4/6 inhibitor initiated on the index date (i.e., abemaciclib, palbociclib, or ribociclib).
The 6-month period preceding the index date was considered as the baseline period, and was used to measure patient characteristics.
Outcomes were measured between the index date and 1) the end of the study period (persistence, switch, HRU, costs) OR 2) the end of the index treatment (adherence, dose modification, frequency of monitoring), as relevant. The end of the study period was defined as the earliest occurrence between the end of continuous enrollment and the end of data availability.
- Conditions
- Metastatic Breast Cancer
- Being tested
- Ribociclib, Palbociclib, Abemaciclib
- Keywords
- Metastatic breast cancer,, CDK4/6,, health resource utilization,, healthcare costs,, treatment patterns
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RibociclibDrug
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: Ribociclib | |
| 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 inpatient (IP) admissions
Healthcare Resource Utilization (HRU) was measured between index date and end of follow-up, and was separately measured during the studied line of therapy, and after the studied line of therapy. Because women have different durations of follow-up, the number of events were reported as the average total number of visits per patient-per-6-months (PPP6M). HRU PPP6M was defined as the total number of visits or services for a patient occurring during the relevant period, reported on a six-month basis.
Measured: From the index date defined as initiation of CDK4/6 inhibitor to the end of follow-up i.e. approximately 6 months (Q1/2001 - Q3/2018)
Number of IP days
HRU was measured between index date and end of follow-up, and was separately measured during the studied line of therapy, and after the studied line of therapy. Because women have different durations of follow-up, the number of events were reported as the average total number of visits per patient-per-6-months (PPP6M). HRU PPP6M was defined as the total number of visits or services for a patient occurring during the relevant period, reported on a six-month basis.
Measured: From the index date defined as initiation of CDK4/6 inhibitor to the end of follow-up i.e. approximately 6 months (Q1/2001 - Q3/2018)
Number of days with durable medical equipment (DME) services
HRU was measured between index date and end of follow-up, and was separately measured during the studied line of therapy, and after the studied line of therapy. Because women have different durations of follow-up, the number of events were reported as the average total number of visits per patient-per-6-months (PPP6M). HRU PPP6M was defined as the total number of visits or services for a patient occurring during the relevant period, reported on a six-month basis.
Measured: From the index date defined as initiation of CDK4/6 inhibitor to the end of follow-up i.e. approximately 6 months (Q1/2001 - Q3/2018)
Number of days with emergency department (ED) visits
HRU was measured between index date and end of follow-up, and was separately measured during the studied line of therapy, and after the studied line of therapy. Because women have different durations of follow-up, the number of events were reported as the average total number of visits per patient-per-6-months (PPP6M). HRU PPP6M was defined as the total number of visits or services for a patient occurring during the relevant period, reported on a six-month basis.
Measured: From the index date defined as initiation of CDK4/6 inhibitor to the end of follow-up i.e. approximately 6 months (Q1/2001 - Q3/2018)
Number of days with outpatient (OP) services or visits
OP services included:
- Home care services
- Skilled nursing facility services
- Office visits
- Ambulatory surgical center visits
- Other OP services
Measured: From the index date defined as initiation of CDK4/6 inhibitor to the end of follow-up i.e. approximately 6 months (Q1/2001 - Q3/2018)
Other medical services
In addition to the all-cause HRU components, specific condition-related HRU was also analyzed. Conditions considered included those frequently encountered in clinical trials of CDK4/6 inhibitors. This included the number of days with medical services, number of IP days, number of non-IP days, and proportion of women with at least one medical service associated with a diagnosis for the following conditions:
- Thrombolic events (e.g., thrombophlebitis/deep vein thrombosis)
- Pulmonary embolism
- QT prolongation events
- Infections
- Anemia
- Neutropenia
- Leukopenia
- Thrombocytopenia
Measured: From the index date defined as initiation of CDK4/6 inhibitor to the end of follow-up i.e. approximately 6 months (Q1/2001 - Q3/2018)
Total healthcare costs (medical service + pharmacy costs)
Medical service costs included:
IP costs, ER costs, OP costs, DME costs, Laboratory test costs, Medical drug administration costs and OP costs - excluding drug administration costs
Pharmacy costs (pharmacy costs covered by pharmacy benefits) included:
CDK4/6 inhibitor costs, Endocrine and chemotherapy costs and Other drug costs
Measured: From the index date defined as initiation of CDK4/6 inhibitor to the end of follow-up i.e. approximately 6 months (Q1/2001 - Q3/2018)
Secondary outcomes (2)
Treatment patterns
Treatment patterns included:
- Treatment persistence
- Treatment switches
- Treatment adherence (proportion of days covered, while on treatment)
- Dose modification (dose decrease, dose increase)
- Use of concomitant medication
Measured: From the index date defined as initiation of CDK4/6 inhibitor to the end of follow-up i.e. approximately 6 months (Q1/2001 - Q3/2018)
Monitoring
electrocardiogram [EKG], hematologic tests, hepatic function tests, imaging
Measured: From the index date defined as initiation of CDK4/6 inhibitor to the end of follow-up i.e. approximately 6 months (Q1/2001 - Q3/2018)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start8 May 2020
- Primary completion31 Jul 2020
- Study completion31 Jul 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
- 4,320 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
- NCT05153135
- Sponsor's protocol ID
- CLEE011AUS65
- Status last verified
- Dec 2021
- First submitted
- 29 Nov 2021
- Last updated
- 21 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 21 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Description of Treatment Patterns and Description and Comparison of Healthcare Resource Utilization and Costs of Women With Metastatic HR+/HER2- Breast Cancer Treated With CDK4/6 Inhibitors
- ClinicalTrials.gov ID
- NCT05153135
- Acronym / sponsor ID
- CLEE011AUS65
- Conditions
- Metastatic Breast Cancer
- Keywords
- Metastatic breast cancer,, CDK4/6,, health resource utilization,, healthcare costs,, treatment patterns
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,320 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 8 May 2020 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 10 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.
The study was an observational, retrospective cohort design, using US administrative insurance claims data, to better understand Healthcare resource utilization (HRU) and healthcare costs among women with mBC initiated on a CDK4/6 inhibitor.
Detailed description
This study used an observational, retrospective cohort design, using US administrative insurance claims data, previously employed in an existing project, to better understand HRU and healthcare costs among women with mBC initiated on a CDK4/6 inhibitor.
Adult women with HR+/HER2- mBC initiated on a CDK4/6 inhibitor were included in the study and were stratified into cohorts based on the first CDK4/6 inhibitor they received (i.e., abemaciclib, palbociclib, or ribociclib), regardless of the line of therapy and menopausal status.
The initiation of the first CDK4/6 inhibitor was defined as the index date. The index treatment was defined as the CDK4/6 inhibitor initiated on the index date (i.e., abemaciclib, palbociclib, or ribociclib).
The 6-month period preceding the index date was considered as the baseline period, and was used to measure patient characteristics.
Outcomes were measured between the index date and 1) the end of the study period (persistence, switch, HRU, costs) OR 2) the end of the index treatment (adherence, dose modification, frequency of monitoring), as relevant. The end of the study period was defined as the earliest occurrence between the end of continuous enrollment and the end of data availability.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ribociclib | – | Drug: RibociclibParticipants 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 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study analyses were conducted among HR+/HER2- women with at least one claim for treatment with CDK4/6 inhibitor for mBC
Key inclusion criteria (7 listed)
- Evidence of treatment with a CDK4/6 inhibitor regardless of the line of therapy.
- The initiation of the first CDK4/6 inhibitor was defined as the index date, and the first CDK4/6 inhibitor initiated was defined as the index treatment
- BC diagnosis: Two diagnosis codes of BC (International Classification of Diseases, 9th Revision, Clinical Modification [ICD-9-CM]: 174.xx and International Classification of Diseases, 10th Revision, Clinical Modification [ICD-10-CM]: C50.xx [excluding C50.x2 - male BC]) on two medical service claims separated by at least 30 days
- Metastatic disease diagnosis: At least two medical claims for a secondary neoplasm (ICD-9-CM codes: 196.xx-197.xx, 198.xx, ICD-10-CM codes: C77.xx, C78.xx, C79.xx) on separate dates, with the first one occurring no more than 30 days before the first diagnosis for BC
- HR+/HER2-: At least one prescription fill or administration of an ET (anastrazole, exemestane, ethinyl estradiol, fulvestrant, fluoxymesterone, letrozole, megestrol acetate, tamoxifen, or toremifene), HR+/HER2- therapy (everolimus), or CDK4/6 inhibitor (i.e., abemaciclib, palbociclib, or ribociclib) at any time following the diagnosis of BC, and no claims for treatments indicated for HER2+ BC, including trastuzumab, lapatinib, afatinib, pertuzumab, or ado-trastuzumab, at any time in the data period
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 |
|---|---|---|
| RibociclibParticipants 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 inpatient (IP) admissions
Time frame: From the index date defined as initiation of CDK4/6 inhibitor to the end of follow-up i.e. approximately 6 months (Q1/2001 - Q3/2018)
Healthcare Resource Utilization (HRU) was measured between index date and end of follow-up, and was separately measured during the studied line of therapy, and after the studied line of therapy. Because women have different durations of follow-up, the number of events were reported as the average total number of visits per patient-per-6-months (PPP6M). HRU PPP6M was defined as the total number of visits or services for a patient occurring during the relevant period, reported on a six-month basis.
Number of IP days
Time frame: From the index date defined as initiation of CDK4/6 inhibitor to the end of follow-up i.e. approximately 6 months (Q1/2001 - Q3/2018)
HRU was measured between index date and end of follow-up, and was separately measured during the studied line of therapy, and after the studied line of therapy. Because women have different durations of follow-up, the number of events were reported as the average total number of visits per patient-per-6-months (PPP6M). HRU PPP6M was defined as the total number of visits or services for a patient occurring during the relevant period, reported on a six-month basis.
Number of days with durable medical equipment (DME) services
Time frame: From the index date defined as initiation of CDK4/6 inhibitor to the end of follow-up i.e. approximately 6 months (Q1/2001 - Q3/2018)
HRU was measured between index date and end of follow-up, and was separately measured during the studied line of therapy, and after the studied line of therapy. Because women have different durations of follow-up, the number of events were reported as the average total number of visits per patient-per-6-months (PPP6M). HRU PPP6M was defined as the total number of visits or services for a patient occurring during the relevant period, reported on a six-month basis.
Number of days with emergency department (ED) visits
Time frame: From the index date defined as initiation of CDK4/6 inhibitor to the end of follow-up i.e. approximately 6 months (Q1/2001 - Q3/2018)
HRU was measured between index date and end of follow-up, and was separately measured during the studied line of therapy, and after the studied line of therapy. Because women have different durations of follow-up, the number of events were reported as the average total number of visits per patient-per-6-months (PPP6M). HRU PPP6M was defined as the total number of visits or services for a patient occurring during the relevant period, reported on a six-month basis.
Number of days with outpatient (OP) services or visits
Time frame: From the index date defined as initiation of CDK4/6 inhibitor to the end of follow-up i.e. approximately 6 months (Q1/2001 - Q3/2018)
OP services included: * Home care services * Skilled nursing facility services * Office visits * Ambulatory surgical center visits * Other OP services
Other medical services
Time frame: From the index date defined as initiation of CDK4/6 inhibitor to the end of follow-up i.e. approximately 6 months (Q1/2001 - Q3/2018)
In addition to the all-cause HRU components, specific condition-related HRU was also analyzed. Conditions considered included those frequently encountered in clinical trials of CDK4/6 inhibitors. This included the number of days with medical services, number of IP days, number of non-IP days, and proportion of women with at least one medical service associated with a diagnosis for the following conditions: * Thrombolic events (e.g., thrombophlebitis/deep vein thrombosis) * Pulmonary embolism * QT prolongation events * Infections * Anemia * Neutropenia * Leukopenia * Thrombocytopenia
Total healthcare costs (medical service + pharmacy costs)
Time frame: From the index date defined as initiation of CDK4/6 inhibitor to the end of follow-up i.e. approximately 6 months (Q1/2001 - Q3/2018)
Medical service costs included: IP costs, ER costs, OP costs, DME costs, Laboratory test costs, Medical drug administration costs and OP costs - excluding drug administration costs Pharmacy costs (pharmacy costs covered by pharmacy benefits) included: CDK4/6 inhibitor costs, Endocrine and chemotherapy costs and Other drug costs
2 secondary outcomes
Treatment patterns
Time frame: From the index date defined as initiation of CDK4/6 inhibitor to the end of follow-up i.e. approximately 6 months (Q1/2001 - Q3/2018)
Monitoring
Time frame: From the index date defined as initiation of CDK4/6 inhibitor to the end of follow-up i.e. approximately 6 months (Q1/2001 - Q3/2018)
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 21 Dec 2021.
- Results for CLEE011AUS65 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 7 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 21 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 inpatient (IP) admissions (time frame: From the index date defined as initiation of CDK4/6 inhibitor to the end of follow-up i.e. approximately 6 months (Q1/2001 - Q3/2018)). 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 21 Dec 2021.