CompletedNot Applicable

Real-world Treatment Patterns of Endocrine Based Therapy Among Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor-2-negative (HR+/HER2-) Advanced Breast Cancer: An Analysis of Administrative Claims Data in Japan

Japan1,170 participantsStarted 2019-08-31

Plain-language summary

This is a retrospective observational study focusing on patients diagnosed with advanced breast cancer(ABC) in Japan using de-identified claim data from Medical Data Vision (MDV) database. The primary objective of this study is to describe patient demographics, treatment patterns and treatment duration of palbociclib, and subsequent treatment patterns and treatment duration after palbociclib-based therapy among ABC patients in Japan The secondary objective of the study is to describe patient demographics, treatment patterns of ABC patients and treatment duration of endocrine therapy, and subsequent treatment patterns and treatment duration after endocrine therapy among ABC patients in Japan.

Who can participate

Sex

ALL

See this in plain English?

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

Exclusion criteria

Received a prescription of anti-HER2 therapy (Trastuzumab, Trastuzumab emtansine, Pertuzumab, and Lapatinib tosilate hydrate)

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

Percentage of Participants According to Number of Blood Tests at 1 to 4 Weeks From Palbociclib Treatment Initiation

Timeframe: Anytime between 1 to 4 weeks from palbociclib treatment initiation; available data observed retrospectively over approximately 22 months in this study

Percentage of Participants According to Number of Blood Tests at 5 to 8 Weeks From Palbociclib Treatment Initiation

Timeframe: Anytime between 5 to 8 weeks from palbociclib treatment initiation; available data observed retrospectively over approximately 22 months in this study

Percentage of Participants According to Number of Blood Tests at 9 to 12 Weeks From Palbociclib Treatment Initiation

Timeframe: Anytime between 9 to 12 weeks from palbociclib treatment initiation; available data observed retrospectively over approximately 22 months in this study

Percentage of Participants According to Number of Blood Tests at 13 to 16 Weeks From Palbociclib Treatment Initiation

Timeframe: Anytime between 13 to 16 weeks from palbociclib treatment initiation; available data observed retrospectively over approximately 22 months in this study

Percentage of Participants According to Number of Blood Tests at 17 to 20 Weeks From Palbociclib Treatment Initiation

Timeframe: Anytime between 17 to 20 weeks from palbociclib treatment initiation; available data observed retrospectively over approximately 22 months in this study

Trial details

NCT IDNCT05153187

SponsorPfizer

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2021-06-30

Results submitted2026-03-29

View on ClinicalTrials.gov More Breast Cancer trials

Plain-language summary

Who can participate

Sex

ALL

See this in plain English?

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

Exclusion criteria

Received a prescription of anti-HER2 therapy (Trastuzumab, Trastuzumab emtansine, Pertuzumab, and Lapatinib tosilate hydrate)