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

Completed

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

• Registration Number: NCT06463626
• Lead Sponsor: Novartis

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-04-06
• Primary Completion: 2023-06-27
• Study Completion: 2023-06-27
• Status Verified: 2024-06
• Study First Submitted: 2024-06-10
• Study First Submitted QC: 2024-06-16
• Last Update Submitted: 2024-06-16
• Study First Posted: 2024-06-18
• Last Update Posted: 2024-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 121

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean Age	Baseline, defined as start of treatment with CDKi
Initial Dose of CDKi 4/6	Baseline, defined as start of treatment with CDKi
Number of Pre-menopause Patients by CDKi 4/6	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 Without Concomitant Therapy	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, Palbociclib-treated Patients by Type of Concomitant Therapy	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	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	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 Palbociclib-treated Patients by Type of Concomitant Therapy	Baseline, defined as start of treatment with CDKi
Number of Patients Starting First-Line Therapy with CDKi 4/6	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	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 Ribociclib-treated Patients by Type of Concomitant Therapy	Baseline, defined as start of treatment with CDKi
Number of Pre-menopause Patients Without Concomitant Therapy	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	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	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 Administered Initial Dose of CDKi 4/6 Once per Day	Baseline, defined as start of treatment with CDKi
Number of Pre-menopause, Palbociclib-treated Patients by Type of Aromatase Inhibitor	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	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	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 Palbociclib-treated Patients by Type of Aromatase Inhibitor	Baseline, defined as start of treatment with CDKi
Number of Pre-menopause, Ribociclib-treated Patients by Type of Concomitant Therapy	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	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.

Secondary Outcome Measures

Name	Time	Method
Average Number of Dose Changes Per Patient	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
Number of Patients with at Least One Dose Change	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

Trial Locations

Locations (1)

Novartis Pharmaceuticals; 🇺🇸 East Hanover, New Jersey, United States