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

Novartis

Status: Completed

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

Study type: Observational

Funder types: Industry

Identifiers

NCT06463626

CLEE011APT01

Details and patient eligibility

About

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.

Enrollment: 121 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

121 participants in 1 patient group

CDKi cohort

Description:

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).