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PBI for Breast in Situ Carcinoma of Intermediate Low Risk As Local Adjuvant Treatment

Study acronym: PRISCILLA
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v4
  2. Eligibility criteria expanded, about 2 wordsv3
  3. Start date changed from estimate of Dec 2022 to Jan 9, 2023v2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Screening and advances in breast imaging led to a continuous increase of Ductal Carcinoma in situ (DCIS) diagnosis. Whole breast radiotherapy was reported to be effective in reducing the risk of local recurrence in all analyzed patients and tumor characteristics. In order to de-escalate treatment in low and intermediate DCIS, it is possible to investigate the role of partial breast irradiation (PBI). To date, data from available literature supports the hypothesis that PBI is a safe well tolerated therapy that appears to be equivalent to WBI in terms of efficacy and ultimate breast cosmesis.
Trial Details
NCT Number NCT05663294
Lead Sponsor Istituto Clinico Humanitas
Collaborators: Mediolanum Cardio Research
Conditions
(from sponsor)		 Breast Cancer
Related terms Breast Neoplasms
Enrollment 150 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov