RecruitingNot ApplicableNCT05216900

Breast Reconstruction and Neoadjuvant Radiotherapy

Breast Reconstruction and Neoadjuvant Therapy, a Changing Algorithm


Sponsor

UMC Utrecht

Enrollment

20 participants

Start Date

Apr 1, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether giving radiation therapy before breast removal surgery (mastectomy) — called neoadjuvant radiotherapy — is as safe and effective as the standard approach of giving radiation after surgery. This pilot study is being conducted in the Netherlands and is for women who will need both mastectomy and radiation. **You may be eligible if...** - You are a woman aged 18 or older - You are scheduled to have a mastectomy - You have a confirmed indication for radiation therapy (such as positive lymph nodes or specific high-risk features) - You understand Dutch language well enough to give informed consent **You may NOT be eligible if...** - You have had previous breast cancer or radiation to the breast or armpit area - You have a connective tissue disease (such as lupus or scleroderma) that makes radiation higher risk - You are pregnant or breastfeeding - You have a BMI over 35 or you smoke - You have a T4 tumor (cancer that has grown into the skin or chest wall) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONNeoadjuvant 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.


Locations(1)

Maarse Wiesje

Bilthoven, Utrecht, Netherlands

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NCT05216900


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