Breast Cancer
Conditions
Keywords
metastatic breast cancer, advanced breast cancer, HR+/HER2-
Brief 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.
Interventions
None listed
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Classified According to Treatment Pattern | 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 | 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
| Measure | Time frame |
|---|---|
| Number of Participants Classified According to Type of Treatment Before Introduction of CDK4/6 Inhibitor | From date of ABC/MBC diagnosis until introduction of CDK 4/6 inhibitor(anytime between Jan 2016 to May 2016, approximately 4 months); available data evaluated over approximately 4.5 months of this retrospective study |
| Number of Participants Classified According to Type of Treatment After Introduction of CDK4/6 Inhibitor | From date of introduction of CDK4/6 inhibitor until date of death, date of last follow-up or the end of the study period, whichever came first (approximately 33 months); available data evaluated over approximately 4.5 months of this retrospective study |
Countries
Canada
Participant flow
Recruitment details
Participants diagnosed with hormone receptor-positive (HR+) and human epidermal growth factor receptor 2 negative (HER2)- advanced/metastatic breast cancer (ABC/MBC) between 01-Jan-2016 to 01-Jul-2021 and received a cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) at Sinai Health were included in this retrospective study. Data were extracted from electronic health records until 01-Oct-2021. Available data was evaluated from 12-Oct-2022 to 28-Feb-2023 (approximately 4.5 months).
Pre-assignment details
A total of 48 female participants were included in this study.
Participants by arm
| Arm | Count |
|---|---|
| HR+/HER2- ABC/MBC Participants Participants with HR+/HER2- advanced/metastatic breast cancer who received treatment with CDK4/6 inhibitors) at Sinai Health between 01-Jan-2016 to 01-Oct-2021 were observed in this retrospective study. | 48 |
| Total | 48 |
Baseline characteristics
| Characteristic | HR+/HER2- ABC/MBC Participants | — |
|---|---|---|
| Age, Continuous | 57.9 Years STANDARD_DEVIATION 14 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 48 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 48 |
| other Total, other adverse events | 0 / 48 |
| serious Total, serious adverse events | 0 / 48 |
Outcome results
Primary
Number of Participants Classified According to Treatment Pattern
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.
Time frame: 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
Population: Analysis population included all eligible participants whose data were retrieved and observed in the study. Here Number Analyzed refers to the number of participants evaluable for the specified rows.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HR+/HER2- ABC/MBC Participants | Number of Participants Classified According to Treatment Pattern | 1st line: Palbociclib + ET | 30 Participants |
| HR+/HER2- ABC/MBC Participants | Number of Participants Classified According to Treatment Pattern | 1st line: Palbociclib + ET + goserelin | NA Participants |
| HR+/HER2- ABC/MBC Participants | Number of Participants Classified According to Treatment Pattern | 1st line: Other CDK 4/6i + ET | NA Participants |
| HR+/HER2- ABC/MBC Participants | Number of Participants Classified According to Treatment Pattern | 1st line: Other CDK 4/6i + ET + goserelin | NA Participants |
| HR+/HER2- ABC/MBC Participants | Number of Participants Classified According to Treatment Pattern | 1st line: ET | NA Participants |
| HR+/HER2- ABC/MBC Participants | Number of Participants Classified According to Treatment Pattern | 1st line: Chemotherapy | 7 Participants |
| HR+/HER2- ABC/MBC Participants | Number of Participants Classified According to Treatment Pattern | 2nd line: Palbociclib + ET | NA Participants |
| HR+/HER2- ABC/MBC Participants | Number of Participants Classified According to Treatment Pattern | 2nd line: Palbociclib + ET + goserelin | NA Participants |
| HR+/HER2- ABC/MBC Participants | Number of Participants Classified According to Treatment Pattern | 2nd line: Other CDK 4/6i + ET | 7 Participants |
| HR+/HER2- ABC/MBC Participants | Number of Participants Classified According to Treatment Pattern | 2nd line: Other CDK 4/6i + ET + goserelin | NA Participants |
| HR+/HER2- ABC/MBC Participants | Number of Participants Classified According to Treatment Pattern | 2nd line: Alpelisib + ET | NA Participants |
| HR+/HER2- ABC/MBC Participants | Number of Participants Classified According to Treatment Pattern | 2nd line: ET | NA Participants |
| HR+/HER2- ABC/MBC Participants | Number of Participants Classified According to Treatment Pattern | 2nd line: Chemotherapy | 6 Participants |
| HR+/HER2- ABC/MBC Participants | Number of Participants Classified According to Treatment Pattern | 3rd line: Palbociclib + ET + goserelin | NA Participants |
| HR+/HER2- ABC/MBC Participants | Number of Participants Classified According to Treatment Pattern | 3rd line: Other CDK 4/6i | NA Participants |
| HR+/HER2- ABC/MBC Participants | Number of Participants Classified According to Treatment Pattern | 3rd line: Chemotherapy | 10 Participants |
Secondary
Number of Participants Classified According to Type of Treatment After Introduction of CDK4/6 Inhibitor
Time frame: From date of introduction of CDK4/6 inhibitor until date of death, date of last follow-up or the end of the study period, whichever came first (approximately 33 months); available data evaluated over approximately 4.5 months of this retrospective study
Population: Analysis population included all eligible participants whose data were retrieved and observed in the study. Here Overall Number of Participants Analyzed signifies the number of participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HR+/HER2- ABC/MBC Participants | Number of Participants Classified According to Type of Treatment After Introduction of CDK4/6 Inhibitor | NA Participants |
Secondary
Number of Participants Classified According to Type of Treatment Before Introduction of CDK4/6 Inhibitor
Time frame: From date of ABC/MBC diagnosis until introduction of CDK 4/6 inhibitor(anytime between Jan 2016 to May 2016, approximately 4 months); available data evaluated over approximately 4.5 months of this retrospective study
Population: Analysis population included all eligible participants whose data were retrieved and observed in the study. Here Overall Number of Participants Analyzed signifies the number of participants evaluable for this outcome measure.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HR+/HER2- ABC/MBC Participants | Number of Participants Classified According to Type of Treatment Before Introduction of CDK4/6 Inhibitor | NA Participants |