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

Human Epidermal Growth Factor 2 Negative Carcinoma of Breast Clinical Trial

Official title:

REal-world Patterns of Treatment With CDKi 4/6 for AdVanced BrEast CAncer in PortugaL - REVEAL Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06463626
• Other study ID #: CLEE011APT01
• Status: Completed
• Start date: April 6, 2020
• Est. completion date: June 27, 2023

Study information

• Verified date: June 2024
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: June 27, 2023
• Est. primary completion date: June 27, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Human Epidermal Growth Factor 2 Negative Carcinoma of Breast

Locations

Country	Name	City	State
United States	Novartis Pharmaceuticals	East Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Age		Baseline, defined as start of treatment with CDKi
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Initial Dose of CDKi 4/6		Baseline, defined as start of treatment with CDKi
Primary	Number of Patients Administered Initial Dose of CDKi 4/6 Once per Day		Baseline, defined as start of treatment with CDKi
Primary	Number of Patients Without Concomitant Therapy		Baseline, defined as start of treatment with CDKi
Primary	Number of Palbociclib-treated Patients by Type of Concomitant Therapy		Baseline, defined as start of treatment with CDKi
Primary	Number of Ribociclib-treated Patients by Type of Concomitant Therapy		Baseline, defined as start of treatment with CDKi
Primary	Number of Palbociclib-treated Patients by Type of Aromatase Inhibitor		Baseline, defined as start of treatment with CDKi
Primary	Number of Ribociclib-treated Patients by Type of Aromatase Inhibitor		Baseline, defined as start of treatment with CDKi
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Number of Patients with at Least One Dose Change		Up to 6 months post-initiation of CDKi treatment
Secondary	Average Number of Dose Changes Per Patient		Up to 6 months post-initiation of CDKi treatment
Secondary	Number of Palbociclib-treated Patients by Number of Dose Changes		Up to 6 months post-initiation of CDKi treatment
Secondary	Number of Ribociclib-treated Patients by Number of Dose Changes		Up to 6 months post-initiation of CDKi treatment