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Completed

NCT Number: NCT06463626

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Novartis Pharmaceuticals

East Hanover, New Jersey, 07936, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Mean Age

    Time frame: Baseline, defined as start of treatment with CDKi

  2. Number of Pre-menopause Patients by CDKi 4/6

    Time frame: 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.

  3. Number of Post-menopause Patients by CDKi 4/6

    Time frame: 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.

  4. Number of Patients Starting First-Line Therapy with CDKi 4/6

    Time frame: 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.

  5. Number of Patients Starting Second-Line Therapy with CDKi 4/6

    Time frame: 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.

  6. Initial Dose of CDKi 4/6

    Time frame: Baseline, defined as start of treatment with CDKi

  7. Number of Patients Administered Initial Dose of CDKi 4/6 Once per Day

    Time frame: Baseline, defined as start of treatment with CDKi

  8. Number of Patients Without Concomitant Therapy

    Time frame: Baseline, defined as start of treatment with CDKi

  9. Number of Palbociclib-treated Patients by Type of Concomitant Therapy

    Time frame: Baseline, defined as start of treatment with CDKi

  10. Number of Ribociclib-treated Patients by Type of Concomitant Therapy

    Time frame: Baseline, defined as start of treatment with CDKi

  11. Number of Palbociclib-treated Patients by Type of Aromatase Inhibitor

    Time frame: Baseline, defined as start of treatment with CDKi

  12. Number of Ribociclib-treated Patients by Type of Aromatase Inhibitor

    Time frame: Baseline, defined as start of treatment with CDKi

  13. Number of Pre-menopause Patients Without Concomitant Therapy

    Time frame: 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.

  14. Number of Post-menopause Patients Without Concomitant Therapy

    Time frame: 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.

  15. Number of Pre-menopause, Palbociclib-treated Patients by Type of Concomitant Therapy

    Time frame: 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.

  16. Number of Pre-menopause, Ribociclib-treated Patients by Type of Concomitant Therapy

    Time frame: 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.

  17. Number of Post-menopause, Palbociclib-treated Patients by Type of Concomitant Therapy

    Time frame: 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.

  18. Number of Post-menopause, Ribociclib-treated Patients by Type of Concomitant Therapy

    Time frame: 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.

  19. Number of Pre-menopause, Palbociclib-treated Patients by Type of Aromatase Inhibitor

    Time frame: 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.

  20. Number of Pre-menopause, Ribociclib-treated Patients by Type of Aromatase Inhibitor

    Time frame: 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.

  21. Number of Post-menopause, Palbociclib-treated Patients by Type of Aromatase Inhibitor

    Time frame: 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.

  22. Number of Post-menopause, Ribociclib-treated Patients by Type of Aromatase Inhibitor

    Time frame: 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 outcomes

  1. Number of Patients with at Least One Dose Change

    Time frame: Up to 6 months post-initiation of CDKi treatment

  2. Average Number of Dose Changes Per Patient

    Time frame: Up to 6 months post-initiation of CDKi treatment

  3. Number of Palbociclib-treated Patients by Number of Dose Changes

    Time frame: Up to 6 months post-initiation of CDKi treatment

  4. Number of Ribociclib-treated Patients by Number of Dose Changes

    Time frame: Up to 6 months post-initiation of CDKi treatment

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jun 18, 2024
Registry last updated
Jun 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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