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Hypofractionated Radiotherapy in Breast Cancer Patients With Prosthetic Reconstruction

NCT05491395 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2022-08-08

No results posted yet for this study

Summary

RATIONALE:

Radiotherapy (RT) can be indicated to patients submitted to breast-conserving surgery, but, despite the benefits, adjuvant RT can cause contracture generated by tissue fibrosis in patients with immediate prosthetic reconstruction, which could cause prosthesis loss. The biological explanation of this outcome is not fully understood, but recent advances in the analysis of patient-derived blood can contribute to establishing a connection of molecular alterations related to this clinical outcome.

There is not a consensus about using hypofractionated RT schemes for patients with BCS and breast reconstruction since no studies had investigated the reasons why some patients lose the prosthesis.

PURPOSE: This study will evaluate G3 toxicity rate in breast cancer patients with immediate prosthetic reconstruction, submitted to hypofractionated radiotherapy, analyzing capsular contracture, leakage, infection, and bad positioning in order to demonstrate the noninferiority of Hypo-RT with the conventional RT. Additionally, the molecular profile of blood samples will be investigated in order to find biomarkers related to inflammations processes and response to treatment.

Conditions

Interventions

RADIATION

Hypofractionation

Hypofractionation scheme will comprise 40 Gy in 15 fractions

Sponsors & Collaborators

  • Barretos Cancer Hospital

    lead OTHER

Principal Investigators

  • Marcos D Mattos, MD, MS · Barretos Cancer Hospital

  • Gabriela B Salvador, BS · Barretos Cancer Hospital

  • Wanessa F Altei, PhD · Barretos Cancer Hospital

  • Lais L Almeida, MD · Barretos Cancer Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-27
Primary Completion
2026-05-01
Completion
2029-05-01

Countries

  • Brazil

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 NCT05491395 on ClinicalTrials.gov