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

NCT06463626 | Completed

• 1 other identifier: CLEE011APT01
• Study Type: observational
• Target: 121
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (22)

• 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 Outcomes (4)

• 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

Study Arms (1)

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study.

You may qualify if:

• 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.

You may not qualify if:

• Patients with missing information regarding their date of birth and the date or quantity of the drug dispensed in any assignment were excluded.

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

Novartis Pharmaceuticals

East Hanover, New Jersey, 07936, United States

Location

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: June 18, 2024
• Study Start: April 6, 2020
• Primary Completion: June 27, 2023
• Study Completion: June 27, 2023
• Last Updated: June 18, 2024

Record last verified: 2024-06

Locations

US (1)