Clinical trial NCT06463626: Real-life Treatment Patterns With Cyclin-dependent Kinase Inhibitors in Advanced Breast Cancer in Portugal - REVEAL Study
Official title: REal-world Patterns of Treatment With CDKi 4/6 for AdVanced BrEast CAncer in PortugaL - REVEAL Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hormone-receptor-positive Breast Cancer
Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2024-06-18
Enrollment: 121
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This was a retrospective, noninterventional cohort study.

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Patients with missing information regarding their date of birth and the date or quantity of the drug dispensed in any assignment were excluded.

Primary outcomes:
measure: Mean Age
timeFrame: Baseline, defined as start of treatment with CDKi
measure: Number of Pre-menopause Patients by CDKi 4/6
timeFrame: Baseline, defined as start of treatment with CDKi
measure: Number of Post-menopause Patients by CDKi 4/6
timeFrame: Baseline, defined as start of treatment with CDKi
measure: Number of Patients Starting First-Line Therapy with CDKi 4/6
timeFrame: Baseline, defined as start of treatment with CDKi
measure: Number of Patients Starting Second-Line Therapy with CDKi 4/6
timeFrame: Baseline, defined as start of treatment with CDKi
measure: Initial Dose of CDKi 4/6
timeFrame: Baseline, defined as start of treatment with CDKi
measure: Number of Patients Administered Initial Dose of CDKi 4/6 Once per Day
timeFrame: Baseline, defined as start of treatment with CDKi
measure: Number of Patients Without Concomitant Therapy
timeFrame: Baseline, defined as start of treatment with CDKi
measure: Number of Palbociclib-treated Patients by Type of Concomitant Therapy
timeFrame: Baseline, defined as start of treatment with CDKi
measure: Number of Ribociclib-treated Patients by Type of Concomitant Therapy
timeFrame: Baseline, defined as start of treatment with CDKi
measure: Number of Palbociclib-treated Patients by Type of Aromatase Inhibitor
timeFrame: Baseline, defined as start of treatment with CDKi
measure: Number of Ribociclib-treated Patients by Type of Aromatase Inhibitor
timeFrame: Baseline, defined as start of treatment with CDKi
measure: Number of Pre-menopause Patients Without Concomitant Therapy
timeFrame: Baseline, defined as start of treatment with CDKi
measure: Number of Post-menopause Patients Without Concomitant Therapy
timeFrame: Baseline, defined as start of treatment with CDKi
measure: Number of Pre-menopause, Palbociclib-treated Patients by Type of Concomitant Therapy
timeFrame: Baseline, defined as start of treatment with CDKi
measure: Number of Pre-menopause, Ribociclib-treated Patients by Type of Concomitant Therapy
timeFrame: Baseline, defined as start of treatment with CDKi
measure: Number of Post-menopause, Palbociclib-treated Patients by Type of Concomitant Therapy
timeFrame: Baseline, defined as start of treatment with CDKi
measure: Number of Post-menopause, Ribociclib-treated Patients by Type of Concomitant Therapy
timeFrame: Baseline, defined as start of treatment with CDKi
measure: Number of Pre-menopause, Palbociclib-treated Patients by Type of Aromatase Inhibitor
timeFrame: Baseline, defined as start of treatment with CDKi
measure: Number of Pre-menopause, Ribociclib-treated Patients by Type of Aromatase Inhibitor
timeFrame: Baseline, defined as start of treatment with CDKi
measure: Number of Post-menopause, Palbociclib-treated Patients by Type of Aromatase Inhibitor
timeFrame: Baseline, defined as start of treatment with CDKi
measure: Number of Post-menopause, Ribociclib-treated Patients by Type of Aromatase Inhibitor
timeFrame: Baseline, defined as start of treatment with CDKi
Secondary outcomes:
measure: Number of Patients with at Least One Dose Change
timeFrame: Up to 6 months post-initiation of CDKi treatment
measure: Average Number of Dose Changes Per Patient
timeFrame: Up to 6 months post-initiation of CDKi treatment
measure: Number of Palbociclib-treated Patients by Number of Dose Changes
timeFrame: Up to 6 months post-initiation of CDKi treatment
measure: Number of Ribociclib-treated Patients by Number of Dose Changes
timeFrame: Up to 6 months post-initiation of CDKi treatment
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: