Clinical trial · Observational
A Real-life Study to Learn About the Use and Effects of the CDK4/6 Inhibitors in Canadian Patients With Breast Cancer.
Treatment Patterns And Clinical Outcomes Among Patients Receiving CDK4/6 Inhibitors Combinations For HR+/HER2- Advanced/Metastatic Breast Cancer In A Canadian Real World Setting
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Female patients with HR+/HER2- ABC/MBC who received a CDK4/6i based therapy for their ABC/MBC.
- description
- Female patients who received an oral treatment of CDK4/6i based therapy for their ABC/MBC.
Primary outcomes (1)
- measure
- Number of Participants Classified According to Treatment Pattern
- timeFrame
- From date of ABC/MBC diagnosis until date of death, date of last follow-up or the end of the study period, whichever came first (maximum follow-up of 67.6 months); available data evaluated over approximately 4.5 months of this retrospective study
- description
- Number of participants according to the treatment patterns for first line, second line and third line were reported in this outcome measure. CDK4/6i included abemaciclib, palbociclib and ribociclib. Endocrine therapy (ET) included anastrozole, exemestane, fulvestrant, letrozole and tamoxifen. Chemotherapy included capecitabine, cisplatin, cyclophosphamide, docetaxel, doxorubicin, eribulin, gemcitabine and paclitaxel.
Secondary outcomes (2)
- measure
- Number of Participants Classified According to Type of Treatment Before Introduction of CDK4/6 Inhibitor
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available