Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04134598 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

ExclUsive endocRine Therapy Or Radiation theraPy for Women Aged ≥70 Years Early Stage Breast Cancer

Study acronym: EUROPA
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date: Apr 8, 2025 to Mar 31, 2030v8 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Apr 8, 2030 to Mar 31, 2030
    • Site details revised
    • Publications: details revised at 1 of 3 entries
  2. Primary completion date: Feb 8, 2025 to Apr 8, 2025v7 Show 4 more changesShow less
    • Study completion date: Feb 8, 2030 to Apr 8, 2030
    • Secondary endpoints revised (9)
    • Site contact updated
    • Publications: details revised at 1 of 3 entries
  3. Primary completion date: Jan 15, 2026 to Feb 8, 2025v6 Show 5 more changesShow less
    • Study completion date: Jan 15, 2030 to Feb 8, 2030
    • Interventions: Endocrine Therapy (ET): letrozole, anastrozole, exemestane, tamoxifen (Drug), Partial Breast Irradiation (PBI) (Radiation) to Breast irradiation (RT) (Radiation), Endocrine Therapy (ET): letrozole, anastrozole, exemestane, tamoxifen (Drug)
    • Eligibility criteria shortened, about 13 words
    • Study description expanded, about 153 words
    • Study title shortened, about 1 word
  4. Start date changed from estimate of Jan 15, 2021 to Feb 8, 2021v5
  5. Trial status: Not Yet Recruiting to Recruitingv4 Show 6 more changesShow less
    • Start date: Dec 1, 2020 to Jan 15, 2021
    • Study sites: 0 to 1
    • Primary completion date: Dec 1, 2025 to Jan 15, 2026
    • Study completion date: Dec 1, 2025 to Jan 15, 2030
    • Publications: details revised at 1 of 3 entries
    • Eligibility criteria expanded, about 3 words
Show 2 earlier versionsHide 2 earlier versions
  1. Phase: Phase 2/3 to Phase 3v3 Show 9 more changesShow less
    • Enrollment target: 600 to 926
    • Primary completion date: Mar 1, 2023 to Dec 1, 2025
    • Start date: Mar 1, 2020 to Dec 1, 2020
    • Primary endpoints: 1 to 2
    • Study completion date: Mar 1, 2026 to Dec 1, 2025
    • Eligibility criteria revised
    • Secondary endpoints: 10 to 9
    • Collaborators: 2 to 1
    • Study title shortened, about 3 words
  2. Primary endpoint revised
    • Secondary endpoints revised (10)
    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.
Rationale and relevance for patients and the scientific community. In low risk early stage patients ≥70 years, exclusive radiation therapy (RT) approach might be superior in terms of Health-Related Quality of Life (HRQoL), when compared to exclusive endocrine therapy (ET) following breast-conserving surgery (BCS). Assuming an equal rate of disease control, unnecessary long-term toxicity of ET may be avoided.
Trial Details
NCT Number NCT04134598
Lead Sponsor Azienda Ospedaliero-Universitaria Careggi
Collaborators: University of Florence
Conditions
(from sponsor)		 Breast Cancer
Related terms Breast Neoplasms
Enrollment 926 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov