Recruiting

Hypofractionated Radiotherapy in Breast Cancer Patients With Prosthetic Reconstruction

ClinicalTrials.gov IDNCT05491395

PhaseNA

Enrollment120

SponsorBarretos Cancer Hospital

Age18 Years

SexFEMALE

I'm interested View official listing

Conditions studied

Breast Cancer

About this study

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.

Interventions

Radiation: Hypofractionation — Hypofractionation scheme will comprise 40 Gy in 15 fractions

Primary outcomes

Assess the G3 toxicity rate (2 years)

Eligibility information

Inclusion Criteria: * Women with confirmed histological diagnosis of invasive ductal carcinoma and lobular breast carcinoma; * Radical mastectomy with immediate reconstruction with a prosthesis; * Patients indicated for adjuvant RT; * Any lymph node status; * With or without adjuvant chemotherapy; * ECOG performance status from 0-2; * \> 18 years old; * Informed Consent Form applied before any study-specific procedure. Exclusion Criteria: * Another histological diagnosis than invasive ductal carcinoma or lobular carcinoma; * Previous history of neoplasm and/or radiotherapy and/ or quimiotherapy before this study; * Distant metastatic disease; * Palliative treatment; * Patients with scleroderma / systemic lupus erythematosus.

Study locations

Radiation Oncology Department, Barretos, São Paulo 14784-400 Brazil

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-01.