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

NCT ID: NCT06463626

Last Updated: 2024-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

121 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-06

Study Completion Date

2023-06-27

Brief Summary

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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

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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).

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Pharmaceuticals

East Hanover, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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CLEE011APT01

Identifier Type: -

Identifier Source: org_study_id

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