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Single-fraction APBI for Early-stage Breast Cancer With Favorable Histological Subtypes (Breast-1F)

Study acronym: Breast-1F
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv5
  2. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jul 1, 2025 to Jul 25, 2025 · Site details revisedv4 Show 2 more changesShow less
    • Start date changed from estimate of Jul 1, 2025 to Jul 25, 2025
    • Site details revised
  3. Start date: May 1, 2025 to Jul 1, 2025 Primary completion date: May 31, 2029 to Jun 30, 2029 · Completion date: May 31, 2035 to Jun 30, 2035v3 Show 2 more changesShow less
    • Primary completion date: May 31, 2029 to Jun 30, 2029
    • Completion date: May 31, 2035 to Jun 30, 2035
  4. Primary endpoint revised Eligibility criteria expanded, about 20 words · Secondary endpoints revised (14) · Study description expanded, about 29 wordsv2 Show 3 more changesShow less
    • Eligibility criteria expanded, about 20 words
    • Secondary endpoints revised (14)
    • Study description expanded, about 29 words

    See this version in full on ClinicalTrials.gov ↗

  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
IRCCS San Raffaele
234 trials monitored
See 1 trial at risk
Breast Cancer
5,213 trials monitored
See 271 trials at risk
This is a prospective, randomized, monocentric, non-inferiority interventional clinical study comparing an Accelerated Partial Breast Irradiation (APBI) for the surgical bed of early-stage breast cancer patients with favorable histological subtypes, using stereotactic radiotherapy in a single dose of 15.5 Gy with Simultaneous Integrated Boost (SIB) to 21 Gy (study treatment, delivered in a single fraction) versus multifractionated radiotherapy of 30 Gy in 5 fractions (standard treatment, delivered in 5 fractions).
Trial Details
NCT Number NCT06946238
Lead Sponsor IRCCS San Raffaele
Conditions Breast Cancer
Enrollment 311 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov