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

NCT05663294 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-02-03

No results posted yet for this study

Summary

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.

Conditions

Interventions

RADIATION

external beams radiotherapy

External beam radiation therapy uses high doses of radiation to destroy cancer cells and shrink tumors. A large machine aims radiation at the cancer. The allowed schedules for external beams radiotherapy are: * 40 Gy in 15 fractions; * 30 Gy in 5 fractions; * 40 Gy or 38.5 in 10 twice-daily fractions (each daily dose must be separated by at least 6 hours).

RADIATION

brachytherapy

Brachytherapy is a form of radiation therapy where a sealed radiation source is placed inside or next to the area requiring treatment. The schedule for brachytherapy are: * 32 Gy in 8 twice-daily fractions for HDR; * 30.3 Gy in 7 twice-daily fractions for HDR; * 50Gy 0.60-0.80 Gy/hour (1 pulse/hour, 24 hours/day) for PDR.

Sponsors & Collaborators

  • Mediolanum Cardio Research

    collaborator OTHER

  • Istituto Clinico Humanitas

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
41 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-09
Primary Completion
2029-12-31
Completion
2029-12-31

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05663294 on ClinicalTrials.gov