CompletedEarly Phase 1

Treatment of Metastatic Breast Cancer With Fulvestrant Plus Palbociclib or Tamoxifen Plus Palbociclib

United States7 participantsStarted 2018-04-24

Plain-language summary

To assess longitudinal changes in allele frequency of ESR1 mutation in plasma in patients treated with Fulvestrant plus palbociclib compared to tamoxifen plus palbociclib

Who can participate

Age range

18 Years

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.

Inclusion criteria

. Signed informed consent
. Patients must have histologically or cytologically confirmed invasive breast cancer that is ER+ (\>1% staining) with radiographical or clinical evidence of metastatic disease
. Prior therapies:
. Patients must have previously received an aromatase inhibitor in the adjuvant, neo-adjuvant or metastatic setting.
. Patients must have previously received palbociclib in the adjuvant, neo- adjuvant or metastatic setting. If patient is currently taking palbociclib at time of screening for the trial they may continue taking palbociclib.
. The minimum duration of AI in the adjuvant setting is 2 years.
. There is no minimum duration of AI in the metastatic setting or neoadjuvant setting.
. Patients may have been previously treated with an mTOR inhibitor or other investigational agent in addition to an aromatase inhibitor.

Exclusion criteria

. Prior therapy exclusions:
. Prior therapy with fulvestrant

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

Progression-free Survival (PFS)

Timeframe: Up to 3 years and 351 days

Trial details

NCT IDNCT02913430

SponsorShannon Puhalla

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-04-12

Results submitted2023-04-05

View on ClinicalTrials.gov More Metastatic Breast Cancer trials