N/A
N=48
A Real-life Study to Learn About the Use and Effects of the CDK4/6 Inhibitors in Canadian Patients With Breast Cancer.
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT05770713 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Number of Participants Classified According to Treatment Pattern — 30; NA; NA; NA Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Pfizer
- Primary completion
- Feb 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Classified According to Treatment Pattern |
30; NA; NA; NA; NA; 7 | — |
| SECONDARY Number of Participants Classified According to Type of Treatment Before Introduction of CDK4/6 Inhibitor |
NA | — |
| SECONDARY Number of Participants Classified According to Type of Treatment After Introduction of CDK4/6 Inhibitor |
NA | — |
Summary
CDK4/6 inhibitors are approved medicines indicated for the treatment of a kind of advanced/metastatic breast cancer, called hormone receptors positive (HR+)/ Human epidermal growth factor receptor 2 negative (HER2-) disease. They are given orally in combination with hormonal therapies.
The purpose of this study is to better understand how the CDK4/6 inhibitors combinations are used in real-life conditions and their clinical impact for the treatment of Canadian patients affected by (HR+)/ (HER2-) advanced breast cancer (ABC) or metastatic breast cancer (MBC).
Female patients aged 18 years old or more presenting the following conditions will be selected for the study:
* HR+/HER2- breast cancer diagnosis with confirmed metastatic or advanced disease
* Diagnosis of ABC/MBC between 01 January 2016 and 01 July 2021
* Treatment with CDK4/6 inhibitor
Information will be collected from one single Canadian institution, on each selected real-life patient treated with CDK4/6 inhibitors.
Eligibility Criteria
Inclusion Criteria
- HR+/HER2- breast cancer diagnosis with confirmed metastatic or advanced disease
- Diagnosed with ABC/MBC between 01 Jan 2016 and 01 July 2021
- Treatment with CDK4/6 inhibitor
Exclusion Criteria
- Patient does not have ABC/MBC
- Patient has indicated HR- or HER2+ status
- Patient received a CDK4/6i as part of a clinical trial
Data sourced from ClinicalTrials.gov (NCT05770713). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.