CompletedNot Applicable

A Study to Understand the Use of Palbociclib in Canadian Patients With Breast Cancer That Has Spread to Other Organs

Canada472 participantsStarted 2023-10-06

Plain-language 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. 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Estimate the median Duration of Treatment (DoT)

Timeframe: Time index of approximately 01 Jan 2016 to 31 March 2022

Trial details

NCT IDNCT06003114

SponsorPfizer

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-02-22

View on ClinicalTrials.gov More Breast Cancer trials