Real-life Treatment Patterns With Cyclin-dependent Kinase Inhibitors in Advanced Breast Cancer in Portugal - REVEAL Study

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.

Study Overview

• Status: Completed
• Conditions: Human Epidermal Growth Factor 2 Negative Carcinoma of Breast; Hormone-receptor-positive Breast Cancer

• Study Type: Observational
• Enrollment (Actual): 121

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • East Hanover, New Jersey, United States, 07936
      • Novartis Pharmaceuticals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Age		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.	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.	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.	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.	Baseline, defined as start of treatment with CDKi
Initial Dose of CDKi 4/6		Baseline, defined as start of treatment with CDKi
Number of Patients Administered Initial Dose of CDKi 4/6 Once per Day		Baseline, defined as start of treatment with CDKi
Number of Patients Without Concomitant Therapy		Baseline, defined as start of treatment with CDKi
Number of Palbociclib-treated Patients by Type of Concomitant Therapy		Baseline, defined as start of treatment with CDKi
Number of Ribociclib-treated Patients by Type of Concomitant Therapy		Baseline, defined as start of treatment with CDKi
Number of Palbociclib-treated Patients by Type of Aromatase Inhibitor		Baseline, defined as start of treatment with CDKi
Number of Ribociclib-treated Patients by Type of Aromatase Inhibitor		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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Baseline, defined as start of treatment with CDKi

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of Patients with at Least One Dose Change	Up to 6 months post-initiation of CDKi treatment
Average Number of Dose Changes Per Patient	Up to 6 months post-initiation of CDKi treatment
Number of Palbociclib-treated Patients by Number of Dose Changes	Up to 6 months post-initiation of CDKi treatment
Number of Ribociclib-treated Patients by Number of Dose Changes	Up to 6 months post-initiation of CDKi treatment

Collaborators and Investigators

• Sponsor: Novartis
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2020
• Primary Completion (Actual): June 27, 2023
• Study Completion (Actual): June 27, 2023

Study Registration Dates

• First Submitted: June 10, 2024
• First Submitted That Met QC Criteria: June 16, 2024
• First Posted (Actual): June 18, 2024

Study Record Updates

• Last Update Posted (Actual): June 18, 2024
• Last Update Submitted That Met QC Criteria: June 16, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: CLEE011APT01