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A Study to See Whether Estrogen Can Slow the Growth of Some ER Positive Breast Cancers

Study acronym: PRESTO
StatusActive, Not Recruiting
PhasePhase 2
Started
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Record History

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  1. Minor Re-verified, no change to tracked fieldsv12
  2. Minor Study completion date: Jan 2027 to Jun 2028v11
  3. Minor Re-verified, no change to tracked fieldsv10
  4. Notable Primary completion date changed from estimate of Jul 2017 to Jul 30, 2018
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 20 to confirmed 19
    • Site details revised
    v9
  5. Notable Primary endpoint revised
    • Eligibility criteria expanded, about 21 words
    • Secondary endpoints revised (2)
    • Study description expanded, about 1 word
    v8
Show 6 earlier versionsHide 6 earlier versions
  1. Minor 2 versions Re-verified since Dec 31, 2015, no change to tracked fieldsv6-v7
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jul 2015 to Aug 2015
    • Site details revised
    v5
  3. Notable Primary endpoint revised
    • Secondary endpoints: 1 to 2
    v4
  4. Minor Eligibility criteria revisedv3
  5. Notable Start date: Dec 2014 to Jul 2015
    • Primary completion date: Jan 2017 to Jul 2017
    • Study completion date: Jan 2017 to Jan 2027
    v2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Some breast cancers have estrogen receptors (ER+). The investigators know that some ER+ tumours can be cured by hormone therapy alone while other ER+ breast cancers cannot. Currently, there is no perfect way to tell these groups apart nor do the investigators know why some respond when others do not. Research findings suggest that the two types of ER+ breast cancers differ in their response to estrogen with estrogen being toxic to one type and not the other. For those tumours that find estrogen toxic, this may explain why tumours only start to grow when estrogen levels decrease after menopause. The purpose of this study is to see whether a two-week treatment of estrogen equal to pre-menopausal estrogen levels will decrease the rate at which patients' ER+ tumours grow. This will be done by comparing the growth rate in the tissue removed during standard of care surgery after patients have been treated with 7-14 days of estrogen prior to that surgery.
Trial Details
NCT Number NCT02238808
Lead Sponsor AHS Cancer Control Alberta
Conditions
(from sponsor)
Estrogen Receptor Positive Breast Cancer
Enrollment 19 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov