Breast CancerNCT06003114
A Study to Understand the Use of Palbociclib in Canadian Patients With Breast Cancer That Has Spread to Other Organs
An observational study of Breast Cancer, run by Pfizer at 1 site in Canada.
Trial summary
The purpose of this real-world study is to understand the use of palbociclib as first treatment for Hormone receptor positive (HR+) and Human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer in Canada (PALCAN). The real-world study is not a research study. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Palbociclib
- Type of treatment
- Pill or oral medicine
- How many people
- 472 participants
- Where
- 1 siteCanada
- Study dates
- 6 Oct 2023to 22 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Treatment of Canadian women patients on palbociclib with HR+/HER2- metastatic breast cancer
Who may be able to join
- Received at least one cycle of palbociclib as first line therapy for metastatic breast cancer between 01 January 2016 and 31 December 2022
- Histologically confirmed HR+/HER2- metastatic breast cancer
- Minimum of 3 months available follow-up on palbociclib
Who cannot join
- Received a different CDK4/6 inhibitor before palbociclib in the first line
- Received other systemic therapy, including hormone therapy, 15-60 days prior to initiation of palbociclib
- Invalid or incomplete records (more specifically, complete duration of treatment on palbociclib, endocrine therapy or LHRH)
- Death date recorded on or before the date of index date
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real-World Utilization of Palbociclib as 1L Treatment in Canadian HR+/HER2-women Breast Cancer Patients
The purpose of this real-world study is to understand the use of palbociclib as first treatment for Hormone receptor positive (HR+) and Human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer in Canada (PALCAN).
The real-world study is not a research study. It involves real patients who receive medicines prescribed by their doctors in the real world. Metastatic breast cancer is the type which has spread from breast to other organs.
Read more
HR positive stands for Hormone-receptor cells that have a protein on their surface that binds to one of 2 types of hormones. They are estrogen or progesterone. Both these hormones help cancer cells grow.
HER2 negative describes cells that have a small amount or none of a protein called HER2 on their surface. In normal cells, HER2 helps control cell growth. Cancer cells that are HER2 negative may grow more slowly and are less likely to come back or spread to other parts of the body.
This study will mainly measure:
- duration of treatment (from start of treatment till end of treatment) among a group of patients taking palbociclib (Ibrance) in combination with hormone therapy as first line treatment for HR+ HER2- metastatic breast cancer.
- Conditions
- Breast Cancer
- Being tested
- Palbociclib
- Keywords
- Metastatic breast cancer (MBC), Human epidermal growth factor receptor 2 negative (HER2-), Hormone receptor positive (HR+), First line, Real world
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PalbociclibDrug
Also called Ibrance
Participants taking oral palbociclib as prescribed in first-line treatment.
| Study group | Role | What they receive |
|---|---|---|
| First-line patients on Palbociclib | Participants taking oral palbociclib as prescribed in first-line treatment Receives: Drug: Palbociclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate the median Duration of Treatment (DoT)
Measured: Time index of approximately 01 Jan 2016 to 31 March 2022
Secondary outcomes (5)
Number of patients with treatment discontinuation at one-year intervals
Measured: Time index of approximately 01 Jan 2016 to 31 March 2022
Number of patients starting at initial dose
Measured: Time index of approximately 01 Jan 2016 to 31 March 2022
Time to chemotherapy
Measured: Time index of approximately 01 Jan 2016 to 31 March 2022
Clinical Characteristics of Patients
Measured: Time index of approximately 01 Jan 2016 to 31 March 2022
Demographical Characteristics of Patients
Measured: Time index of approximately 01 Jan 2016 to 31 March 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start6 Oct 2023
- Primary completion22 Feb 2024
- Study completion22 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 472 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
- NCT06003114
- Sponsor's protocol ID
- A5481183
- Other IDs
- PALCAN
- Status last verified
- Apr 2026
- First submitted
- 10 Aug 2023
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Utilization of Palbociclib as 1L Treatment in Canadian HR+/HER2-women Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT06003114
- Acronym / sponsor ID
- A5481183
- Conditions
- Breast Cancer
- Keywords
- Metastatic breast cancer (MBC), Human epidermal growth factor receptor 2 negative (HER2-), Hormone receptor positive (HR+), First line, Real world
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 472 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 6 Oct 2023 (actual)
- Primary completion
- 22 Feb 2024 (actual)
- Study completion
- 22 Feb 2024 (actual)
- First posted
- 21 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this real-world study is to understand the use of palbociclib as first treatment for Hormone receptor positive (HR+) and Human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer in Canada (PALCAN).
The real-world study is not a research study. It involves real patients who receive medicines prescribed by their doctors in the real world. Metastatic breast cancer is the type which has spread from breast to other organs.
HR positive stands for Hormone-receptor cells that have a protein on their surface that binds to one of 2 types of hormones. They are estrogen or progesterone. Both these hormones help cancer cells grow.
HER2 negative describes cells that have a small amount or none of a protein called HER2 on their surface. In normal cells, HER2 helps control cell growth. Cancer cells that are HER2 negative may grow more slowly and are less likely to come back or spread to other parts of the body.
This study will mainly measure:
- duration of treatment (from start of treatment till end of treatment) among a group of patients taking palbociclib (Ibrance) in combination with hormone therapy as first line treatment for HR+ HER2- metastatic breast cancer.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| First-line patients on Palbociclib | – | Drug: PalbociclibParticipants taking oral palbociclib as prescribed in first-line treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Treatment of Canadian women patients on palbociclib with HR+/HER2- metastatic breast cancer
Key inclusion criteria (3 listed)
- Received at least one cycle of palbociclib as first line therapy for metastatic breast cancer between 01 January 2016 and 31 December 2022
- Histologically confirmed HR+/HER2- metastatic breast cancer
- Minimum of 3 months available follow-up on palbociclib
Key exclusion criteria (4 listed)
- Received a different CDK4/6 inhibitor before palbociclib in the first line
- Received other systemic therapy, including hormone therapy, 15-60 days prior to initiation of palbociclib
- Invalid or incomplete records (more specifically, complete duration of treatment on palbociclib, endocrine therapy or LHRH)
- Death date recorded on or before the date of index date
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PalbociclibAlso: IbranceParticipants taking oral palbociclib as prescribed in first-line treatment. | Drug | First-line patients on Palbociclib |
Primary outcome
Estimate the median Duration of Treatment (DoT)
Time frame: Time index of approximately 01 Jan 2016 to 31 March 2022
5 secondary outcomes
Number of patients with treatment discontinuation at one-year intervals
Time frame: Time index of approximately 01 Jan 2016 to 31 March 2022
Number of patients starting at initial dose
Time frame: Time index of approximately 01 Jan 2016 to 31 March 2022
Time to chemotherapy
Time frame: Time index of approximately 01 Jan 2016 to 31 March 2022
Clinical Characteristics of Patients
Time frame: Time index of approximately 01 Jan 2016 to 31 March 2022
Demographical Characteristics of Patients
Time frame: Time index of approximately 01 Jan 2016 to 31 March 2022
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- 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 4 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 10 Jul 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Estimate the median Duration of Treatment (DoT) (time frame: Time index of approximately 01 Jan 2016 to 31 March 2022). 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 10 Jul 2026.