CompletedNot Applicable

TREATMENT AND MONITORING PATTERNS AND CLINICAL OUTCOMES IN PATIENTS RECEIVING PALBOCICLIB COMBINATION TREATMENT (WITH AI OR FULVESTRANT) FOR HR+/HER2- A/MBC IN A COMMUNITY ONCOLOGY SETTING.

United States1 participantsStarted 2018-03-01

Plain-language summary

This is a retrospective, observational study that will document the treatment and monitoring patterns and clinical outcomes of patients diagnosed with HR+/HER2- a/mBC who received Palbociclib combination therapy with aromatase inhibitors or fulvestrant in the a/mBC community oncology setting.

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.

Exclusion criteria

There are no exclusion criteria for this study.

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

Proportion of patients receiving various cancer treatment regimens

Timeframe: A/MBC diagnosis through end of study (assessed up to 24 months)

Proportion of patients receiving each therapy sequence across lines

Timeframe: A/MBC diagnosis through end of study (assessed up to 24 months)

Treatment persistence

Timeframe: A/MBC diagnosis through end of study (assessed up to 24 months)

Progression Free Survival (PFS)

Timeframe: A/MBC diagnosis through end of study (assessed up to 24 months)

Overall Survival (OS)

Timeframe: A/MBC diagnosis through end of study (assessed up to 24 months)

Tumor response rate

Timeframe: A/MBC diagnosis through end of study (assessed up to 24 months)

Proportion of patients that experience dose adjustment

Timeframe: A/MBC diagnosis through end of study (assessed up to 24 months)

Trial details

NCT IDNCT04498481

SponsorPfizer

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2018-07-01

View on ClinicalTrials.gov More Breast Cancer trials

What they're measuring

Proportion of patients receiving various cancer treatment regimens

Timeframe: A/MBC diagnosis through end of study (assessed up to 24 months)

Proportion of patients receiving each therapy sequence across lines

Timeframe: A/MBC diagnosis through end of study (assessed up to 24 months)

Treatment persistence

Timeframe: A/MBC diagnosis through end of study (assessed up to 24 months)

Progression Free Survival (PFS)

Timeframe: A/MBC diagnosis through end of study (assessed up to 24 months)

Overall Survival (OS)

Timeframe: A/MBC diagnosis through end of study (assessed up to 24 months)

Tumor response rate

Timeframe: A/MBC diagnosis through end of study (assessed up to 24 months)

Proportion of patients that experience dose adjustment

Timeframe: A/MBC diagnosis through end of study (assessed up to 24 months)