Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06507618 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Pre-Operative Window of ET to Inform RT Decisions (POWER II)

Study acronym: POWER II
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Study sites: 5 to 6v8
  2. Study sites: 4 to 5v7
  3. Study sites: 3 to 4
    • Eligibility criteria revised
    v6
  4. Study sites: 2 to 3v5
  5. Study sites: 1 to 2v4
Show 2 earlier versionsHide 2 earlier versions
  1. Enrollment target: 284 to 354v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jul 2024 to Jul 19, 2024
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a Phase III, multisite exploratory study for women ≥ 65 years of age with early stage estrogen receptor positive (ER+) breast cancer. These individuals will be treated randomly assigned to one of two groups: Intervention, treated with 3 months of pre-operative endocrine therapy (pre-ET) OR Control, participants follow standard of care and proceed directly to breast cancer surgery. Both arms will be assessed for tolerance and compliance to the endocrine therapy by patient reported outcome (PRO) measures (patient surveys).
Trial Details
NCT Number NCT06507618
Lead Sponsor University of Virginia
Conditions
(from sponsor)		 Breast Cancer Female
Related terms Breast Neoplasms
Enrollment 354 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov