Hormone-receptor-positive Breast CancerNCT06463626
Real-life Treatment Patterns With Cyclin-dependent Kinase Inhibitors in Advanced Breast Cancer in Portugal - REVEAL Study
An observational study of Hormone-receptor-positive Breast Cancer and Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, run by Novartis at 1 site in United States.
Trial summary
This was a non-interventional (observational), retrospective, cohort study of women with hormone receptor (HR)-positive and human epidermal growth factor receptor-type 2 (HER2)-negative advanced breast cancer who started treatment with cyclin-dependent kinase inhibitors (CDKi) 4/6 (ribociclib or palbociclib) in… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hormone-receptor-positive Breast Cancer, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
- How many people
- 121 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Apr 2020to 27 Jun 2023
- 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: This was a retrospective, noninterventional cohort study.
Who may be able to join
- Female.
- Aged 18 years or older at the time of starting therapy with CDKi 4/6.
- Breast cancer diagnosis.
- At least one record of ribociclib or palbociclib donation during the identification period.
- Registration of the first supply of ribociclib or palbociclib between 1 March 2019 and 31 December 2019.
Who cannot join
- Patients with missing information regarding their date of birth and the date or quantity of the drug dispensed in any assignment were excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Novartis Pharmaceuticals
East Hanover, New Jersey, 07936
About this study
Official title: REal-world Patterns of Treatment With CDKi 4/6 for AdVanced BrEast CAncer in PortugaL - REVEAL Study
This was a non-interventional (observational), retrospective, cohort study of women with hormone receptor (HR)-positive and human epidermal growth factor receptor-type 2 (HER2)-negative advanced breast cancer who started treatment with cyclin-dependent kinase inhibitors (CDKi) 4/6 (ribociclib or palbociclib) in Portugal. This was a study of medication use patterns, based on information from the hospital pharmacies of the participating centers.
Patients who started a CDKi 4/6 (ribociclib or palbociclib) between 1 March 2019 and 31 December 2019 were included and followed through 24 months. A follow-up occurred 6 months after the start of CDKi 4/6 (ribociclib or palbociclib) to quantify the occurrence of dose changes.
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 |
|---|---|---|
| CDKi cohort | Adult women with HR-positive and HER-2-negative advanced breast cancer who started first- or second-line treatment with CDKi 4/6 (ribociclib or palbociclib). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Age
Measured: Baseline, defined as start of treatment with CDKi
Number of Pre-menopause Patients by CDKi 4/6
Menopausal status: if the patient had taken goserelin in the six months before or after starting CDKi, she was considered to be pre-menopausal. In patients without an associated goserelin withdrawal, age was taken into account, and patients aged 50 or over were considered post-menopausal.
Measured: Baseline, defined as start of treatment with CDKi
Number of Post-menopause Patients by CDKi 4/6
Menopausal status: if the patient had taken goserelin in the six months before or after starting CDKi, she was considered to be pre-menopausal. In patients without an associated goserelin withdrawal, age was taken into account, and patients aged 50 or over were considered post-menopausal.
Measured: Baseline, defined as start of treatment with CDKi
Number of Patients Starting First-Line Therapy with CDKi 4/6
Line of therapy: first-line therapy for advanced breast cancer was defined as no previous hormonal treatment in the 12 months prior to starting treatment with CDKi, including patients with concomitant treatment with fulvestrant. Second-line therapy was defined as previous hormonal treatment in the 12 months prior to starting treatment with CDKi.
Measured: Baseline, defined as start of treatment with CDKi
Number of Patients Starting Second-Line Therapy with CDKi 4/6
Line of therapy: first-line therapy for advanced breast cancer was defined as no previous hormonal treatment in the 12 months prior to starting treatment with CDKi, including patients with concomitant treatment with fulvestrant. Second-line therapy was defined as previous hormonal treatment in the 12 months prior to starting treatment with CDKi.
Measured: Baseline, defined as start of treatment with CDKi
Initial Dose of CDKi 4/6
Measured: Baseline, defined as start of treatment with CDKi
Number of Patients Administered Initial Dose of CDKi 4/6 Once per Day
Measured: Baseline, defined as start of treatment with CDKi
Number of Patients Without Concomitant Therapy
Measured: Baseline, defined as start of treatment with CDKi
Number of Palbociclib-treated Patients by Type of Concomitant Therapy
Measured: Baseline, defined as start of treatment with CDKi
Number of Ribociclib-treated Patients by Type of Concomitant Therapy
Measured: Baseline, defined as start of treatment with CDKi
Number of Palbociclib-treated Patients by Type of Aromatase Inhibitor
Measured: Baseline, defined as start of treatment with CDKi
Number of Ribociclib-treated Patients by Type of Aromatase Inhibitor
Measured: Baseline, defined as start of treatment with CDKi
Number of Pre-menopause Patients Without Concomitant Therapy
Menopausal status: if the patient had taken goserelin in the six months before or after starting CDKi, she was considered to be pre-menopausal. In patients without an associated goserelin withdrawal, age was taken into account, and patients aged 50 or over were considered post-menopausal.
Measured: Baseline, defined as start of treatment with CDKi
Number of Post-menopause Patients Without Concomitant Therapy
Menopausal status: if the patient had taken goserelin in the six months before or after starting CDKi, she was considered to be pre-menopausal. In patients without an associated goserelin withdrawal, age was taken into account, and patients aged 50 or over were considered post-menopausal.
Measured: Baseline, defined as start of treatment with CDKi
Number of Pre-menopause, Palbociclib-treated Patients by Type of Concomitant Therapy
Menopausal status: if the patient had taken goserelin in the six months before or after starting CDKi, she was considered to be pre-menopausal. In patients without an associated goserelin withdrawal, age was taken into account, and patients aged 50 or over were considered post-menopausal.
Measured: Baseline, defined as start of treatment with CDKi
Number of Pre-menopause, Ribociclib-treated Patients by Type of Concomitant Therapy
Menopausal status: if the patient had taken goserelin in the six months before or after starting CDKi, she was considered to be pre-menopausal. In patients without an associated goserelin withdrawal, age was taken into account, and patients aged 50 or over were considered post-menopausal.
Measured: Baseline, defined as start of treatment with CDKi
Number of Post-menopause, Palbociclib-treated Patients by Type of Concomitant Therapy
Menopausal status: if the patient had taken goserelin in the six months before or after starting CDKi, she was considered to be pre-menopausal. In patients without an associated goserelin withdrawal, age was taken into account, and patients aged 50 or over were considered post-menopausal.
Measured: Baseline, defined as start of treatment with CDKi
Number of Post-menopause, Ribociclib-treated Patients by Type of Concomitant Therapy
Menopausal status: if the patient had taken goserelin in the six months before or after starting CDKi, she was considered to be pre-menopausal. In patients without an associated goserelin withdrawal, age was taken into account, and patients aged 50 or over were considered post-menopausal.
Measured: Baseline, defined as start of treatment with CDKi
Number of Pre-menopause, Palbociclib-treated Patients by Type of Aromatase Inhibitor
Menopausal status: if the patient had taken goserelin in the six months before or after starting CDKi, she was considered to be pre-menopausal. In patients without an associated goserelin withdrawal, age was taken into account, and patients aged 50 or over were considered post-menopausal.
Measured: Baseline, defined as start of treatment with CDKi
Number of Pre-menopause, Ribociclib-treated Patients by Type of Aromatase Inhibitor
Menopausal status: if the patient had taken goserelin in the six months before or after starting CDKi, she was considered to be pre-menopausal. In patients without an associated goserelin withdrawal, age was taken into account, and patients aged 50 or over were considered post-menopausal.
Measured: Baseline, defined as start of treatment with CDKi
Number of Post-menopause, Palbociclib-treated Patients by Type of Aromatase Inhibitor
Menopausal status: if the patient had taken goserelin in the six months before or after starting CDKi, she was considered to be pre-menopausal. In patients without an associated goserelin withdrawal, age was taken into account, and patients aged 50 or over were considered post-menopausal.
Measured: Baseline, defined as start of treatment with CDKi
Number of Post-menopause, Ribociclib-treated Patients by Type of Aromatase Inhibitor
Menopausal status: if the patient had taken goserelin in the six months before or after starting CDKi, she was considered to be pre-menopausal. In patients without an associated goserelin withdrawal, age was taken into account, and patients aged 50 or over were considered post-menopausal.
Measured: Baseline, defined as start of treatment with CDKi
Secondary outcomes (4)
Number of Patients with at Least One Dose Change
Measured: Up to 6 months post-initiation of CDKi treatment
Average Number of Dose Changes Per Patient
Measured: Up to 6 months post-initiation of CDKi treatment
Number of Palbociclib-treated Patients by Number of Dose Changes
Measured: Up to 6 months post-initiation of CDKi treatment
Number of Ribociclib-treated Patients by Number of Dose Changes
Measured: Up to 6 months post-initiation of CDKi treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start6 Apr 2020
- Primary completion27 Jun 2023
- Study completion27 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hormone-receptor-positive Breast CancerStudies of the same condition, open and under way.
- 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
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06463626
- Sponsor's protocol ID
- CLEE011APT01
- Status last verified
- Jun 2024
- First submitted
- 10 Jun 2024
- Last updated
- 18 Jun 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REal-world Patterns of Treatment With CDKi 4/6 for AdVanced BrEast CAncer in PortugaL - REVEAL Study
- ClinicalTrials.gov ID
- NCT06463626
- Acronym / sponsor ID
- CLEE011APT01
- Conditions
- Hormone-receptor-positive Breast Cancer, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- 6 Apr 2020 (actual)
- Primary completion
- 27 Jun 2023 (actual)
- Study completion
- 27 Jun 2023 (actual)
- First posted
- 18 Jun 2024 (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 was a non-interventional (observational), retrospective, cohort study of women with hormone receptor (HR)-positive and human epidermal growth factor receptor-type 2 (HER2)-negative advanced breast cancer who started treatment with cyclin-dependent kinase inhibitors (CDKi) 4/6 (ribociclib or palbociclib) in Portugal. This was a study of medication use patterns, based on information from the hospital pharmacies of the participating centers.
Patients who started a CDKi 4/6 (ribociclib or palbociclib) between 1 March 2019 and 31 December 2019 were included and followed through 24 months. A follow-up occurred 6 months after the start of CDKi 4/6 (ribociclib or palbociclib) to quantify the occurrence of dose changes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CDKi cohort | – | –Adult women with HR-positive and HER-2-negative advanced breast cancer who started first- or second-line treatment with CDKi 4/6 (ribociclib or palbociclib). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This was a retrospective, noninterventional cohort study.
Key inclusion criteria (5 listed)
- Female.
- Aged 18 years or older at the time of starting therapy with CDKi 4/6.
- Breast cancer diagnosis.
- At least one record of ribociclib or palbociclib donation during the identification period.
- Registration of the first supply of ribociclib or palbociclib between 1 March 2019 and 31 December 2019.
Key exclusion criteria (1 listed)
- Patients with missing information regarding their date of birth and the date or quantity of the drug dispensed in any assignment were excluded.
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
Mean Age
Time frame: Baseline, defined as start of treatment with CDKi
Number of Pre-menopause Patients by CDKi 4/6
Time frame: Baseline, defined as start of treatment with CDKi
Menopausal status: if the patient had taken goserelin in the six months before or after starting CDKi, she was considered to be pre-menopausal. In patients without an associated goserelin withdrawal, age was taken into account, and patients aged 50 or over were considered post-menopausal.
Number of Post-menopause Patients by CDKi 4/6
Time frame: Baseline, defined as start of treatment with CDKi
Menopausal status: if the patient had taken goserelin in the six months before or after starting CDKi, she was considered to be pre-menopausal. In patients without an associated goserelin withdrawal, age was taken into account, and patients aged 50 or over were considered post-menopausal.
Number of Patients Starting First-Line Therapy with CDKi 4/6
Time frame: Baseline, defined as start of treatment with CDKi
Line of therapy: first-line therapy for advanced breast cancer was defined as no previous hormonal treatment in the 12 months prior to starting treatment with CDKi, including patients with concomitant treatment with fulvestrant. Second-line therapy was defined as previous hormonal treatment in the 12 months prior to starting treatment with CDKi.
Number of Patients Starting Second-Line Therapy with CDKi 4/6
Time frame: Baseline, defined as start of treatment with CDKi
Line of therapy: first-line therapy for advanced breast cancer was defined as no previous hormonal treatment in the 12 months prior to starting treatment with CDKi, including patients with concomitant treatment with fulvestrant. Second-line therapy was defined as previous hormonal treatment in the 12 months prior to starting treatment with CDKi.
Initial Dose of CDKi 4/6
Time frame: Baseline, defined as start of treatment with CDKi
Number of Patients Administered Initial Dose of CDKi 4/6 Once per Day
Time frame: Baseline, defined as start of treatment with CDKi
Number of Patients Without Concomitant Therapy
Time frame: Baseline, defined as start of treatment with CDKi
Number of Palbociclib-treated Patients by Type of Concomitant Therapy
Time frame: Baseline, defined as start of treatment with CDKi
Number of Ribociclib-treated Patients by Type of Concomitant Therapy
Time frame: Baseline, defined as start of treatment with CDKi
Number of Palbociclib-treated Patients by Type of Aromatase Inhibitor
Time frame: Baseline, defined as start of treatment with CDKi
Number of Ribociclib-treated Patients by Type of Aromatase Inhibitor
Time frame: Baseline, defined as start of treatment with CDKi
Number of Pre-menopause Patients Without Concomitant Therapy
Time frame: Baseline, defined as start of treatment with CDKi
Menopausal status: if the patient had taken goserelin in the six months before or after starting CDKi, she was considered to be pre-menopausal. In patients without an associated goserelin withdrawal, age was taken into account, and patients aged 50 or over were considered post-menopausal.
Number of Post-menopause Patients Without Concomitant Therapy
Time frame: Baseline, defined as start of treatment with CDKi
Menopausal status: if the patient had taken goserelin in the six months before or after starting CDKi, she was considered to be pre-menopausal. In patients without an associated goserelin withdrawal, age was taken into account, and patients aged 50 or over were considered post-menopausal.
Number of Pre-menopause, Palbociclib-treated Patients by Type of Concomitant Therapy
Time frame: Baseline, defined as start of treatment with CDKi
Menopausal status: if the patient had taken goserelin in the six months before or after starting CDKi, she was considered to be pre-menopausal. In patients without an associated goserelin withdrawal, age was taken into account, and patients aged 50 or over were considered post-menopausal.
Number of Pre-menopause, Ribociclib-treated Patients by Type of Concomitant Therapy
Time frame: Baseline, defined as start of treatment with CDKi
Menopausal status: if the patient had taken goserelin in the six months before or after starting CDKi, she was considered to be pre-menopausal. In patients without an associated goserelin withdrawal, age was taken into account, and patients aged 50 or over were considered post-menopausal.
Number of Post-menopause, Palbociclib-treated Patients by Type of Concomitant Therapy
Time frame: Baseline, defined as start of treatment with CDKi
Menopausal status: if the patient had taken goserelin in the six months before or after starting CDKi, she was considered to be pre-menopausal. In patients without an associated goserelin withdrawal, age was taken into account, and patients aged 50 or over were considered post-menopausal.
Number of Post-menopause, Ribociclib-treated Patients by Type of Concomitant Therapy
Time frame: Baseline, defined as start of treatment with CDKi
Menopausal status: if the patient had taken goserelin in the six months before or after starting CDKi, she was considered to be pre-menopausal. In patients without an associated goserelin withdrawal, age was taken into account, and patients aged 50 or over were considered post-menopausal.
Number of Pre-menopause, Palbociclib-treated Patients by Type of Aromatase Inhibitor
Time frame: Baseline, defined as start of treatment with CDKi
Menopausal status: if the patient had taken goserelin in the six months before or after starting CDKi, she was considered to be pre-menopausal. In patients without an associated goserelin withdrawal, age was taken into account, and patients aged 50 or over were considered post-menopausal.
Number of Pre-menopause, Ribociclib-treated Patients by Type of Aromatase Inhibitor
Time frame: Baseline, defined as start of treatment with CDKi
Menopausal status: if the patient had taken goserelin in the six months before or after starting CDKi, she was considered to be pre-menopausal. In patients without an associated goserelin withdrawal, age was taken into account, and patients aged 50 or over were considered post-menopausal.
Number of Post-menopause, Palbociclib-treated Patients by Type of Aromatase Inhibitor
Time frame: Baseline, defined as start of treatment with CDKi
Menopausal status: if the patient had taken goserelin in the six months before or after starting CDKi, she was considered to be pre-menopausal. In patients without an associated goserelin withdrawal, age was taken into account, and patients aged 50 or over were considered post-menopausal.
Number of Post-menopause, Ribociclib-treated Patients by Type of Aromatase Inhibitor
Time frame: Baseline, defined as start of treatment with CDKi
Menopausal status: if the patient had taken goserelin in the six months before or after starting CDKi, she was considered to be pre-menopausal. In patients without an associated goserelin withdrawal, age was taken into account, and patients aged 50 or over were considered post-menopausal.
4 secondary outcomes
Number of Patients with at Least One Dose Change
Time frame: Up to 6 months post-initiation of CDKi treatment
Average Number of Dose Changes Per Patient
Time frame: Up to 6 months post-initiation of CDKi treatment
Number of Palbociclib-treated Patients by Number of Dose Changes
Time frame: Up to 6 months post-initiation of CDKi treatment
Number of Ribociclib-treated Patients by Number of Dose Changes
Time frame: Up to 6 months post-initiation of CDKi treatment
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 18 Jun 2024.
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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 Hormone-receptor-positive Breast Cancer and Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, run by Novartis 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 18 Jun 2024. 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?
Mean Age (time frame: Baseline, defined as start of treatment with CDKi). The study lists 22 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 18 Jun 2024.