Real-life Treatment Patterns With Cyclin-dependent Kinase Inhibitors in Advanced Breast Cancer in Portugal - REVEAL Study
NCT Number: NCT06463626
Status: COMPLETED
Study Type: OBSERVATIONAL
Conditions: Hormone-receptor-positive Breast Cancer|Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
Sponsor: Novartis
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 121
Study Design: Observational Model: |Time Perspective: p
Start Date: 2020-04-06
Completion Date: 2023-06-27
Locations: Novartis Pharmaceuticals, East Hanover, New Jersey, 07936, United States

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.

Primary Outcome Measures: 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: 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