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Breast Reconstruction and Neoadjuvant Radiotherapy

NCT05216900 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-06-21

No results posted yet for this study

Summary

The purpose the BRENAR pilot study is to assess acute post-surgical complications following mastectomy and immediate breast reconstruction after neoadjuvant radiotherapy (NART). The investigators hypothesize that NART will avoid the negative effects of postmastectomy radiotherapy (PMRT) on the capsule of an implant, or on the skin and underlying tissue of an autologous flap, and would therefore lead to better cosmetic results, better quality of life and less complications compared to PMRT. If this hypothesis is confirmed, NART would allow more patients to undergo an immediate reconstruction resulting in superior cosmetic results and quality of life. Furthermore, the use of RT in a neoadjuvant setting could potentially result in a shorter overall loco-regional treatment time from diagnosis to receiving the last locoregional treatment. However, this pilot study will mainly assess whether or not the post-surgical complications of breast reconstruction with NART are acceptable. Further study to investigate long term quality of life and oncologic follow-up results will be conducted after this pilot study, if complication rates are acceptable.

Conditions

Interventions

RADIATION

Neoadjuvant radiotherapy

The study examines the delivery NART. In case of neoadjuvant chemotherapy, RT will start 6-8 weeks after the last course of chemotherapy. A dose of 15 x 2.67 Gy 5 fractions per week, or a biologically equivalent dose will be applied. A mastectomy and a direct breast reconstruction will be performed, approximately 2-6 weeks after latest radiotherapy treatment. Breast reconstruction can be separated in the types of reconstruction, either reconstruction with a silicone implant or with only autologous tissue, of which the most common flap used is the Deep Inferior Epigastric Perforator (DIEP) flap.

Sponsors & Collaborators

  • Alexander Monro Hospital, Bilthoven

    collaborator UNKNOWN

  • Amsterdam UMC

    collaborator OTHER

  • Cancer Center Amsterdam grant for innovative research

    collaborator UNKNOWN

  • UMC Utrecht

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2025-12-01
Completion
2026-12-04

Countries

  • Netherlands

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 NCT05216900 on ClinicalTrials.gov