Breast CancerNCT05770713
A Real-life Study to Learn About the Use and Effects of the CDK4/6 Inhibitors in Canadian Patients With Breast Cancer.
An observational study of Breast Cancer, run by Pfizer at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- Type of treatment
- Pill or oral medicine
- How many people
- 48 participants
- Where
- 1 siteCanada
- Study dates
- 12 Oct 2022to 28 Feb 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female patients diagnosed with HR+/HER2- ABC/MBC who received a CDK4/6 inhibitor at Sinai Health, Canada during the study period.
Who may be able to join
- 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
Who cannot join
- Patient does not have ABC/MBC
- Patient has indicated HR- or HER2+ status
- Patient received a CDK4/6i as part of a clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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).
Read more
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
- Breast Cancer
- Keywords
- metastatic breast cancer, advanced breast cancer, HR+/HER2-
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Female patients with HR+/HER2- ABC/MBC who received a CDK4/6i based therapy for their ABC/MBC. | Female patients who received an oral treatment of CDK4/6i based therapy for their ABC/MBC. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Secondary outcomes (2)
Number of Participants Classified According to Type of Treatment Before Introduction of CDK4/6 Inhibitor
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start12 Oct 2022
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05770713
- Sponsor's protocol ID
- A5481178
- Status last verified
- Feb 2024
- First submitted
- 5 Mar 2023
- Last updated
- 22 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05770713
- Acronym / sponsor ID
- A5481178
- Conditions
- Breast Cancer
- Keywords
- metastatic breast cancer, advanced breast cancer, HR+/HER2-
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 12 Oct 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 15 Mar 2023 (actual)
- Results
- Posted 22 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Female patients with HR+/HER2- ABC/MBC who received a CDK4/6i based therapy for their ABC/MBC. | – | –Female patients who received an oral treatment of CDK4/6i based therapy for their ABC/MBC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients diagnosed with HR+/HER2- ABC/MBC who received a CDK4/6 inhibitor at Sinai Health, Canada during the study period.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Patient does not have ABC/MBC
- Patient has indicated HR- or HER2+ status
- Patient received a CDK4/6i as part of a clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants Classified According to Treatment Pattern
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
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.
2 secondary outcomes
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
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Pfizer at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Classified According to Treatment Pattern (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2024; AzTrials last refreshed its copy on 31 Oct 2026.