Actively Recruiting
Breast Reconstruction and Neoadjuvant Radiotherapy
Led by UMC Utrecht · Updated on 2024-06-21
20
Participants Needed
1
Research Sites
191 weeks
Total Duration
On this page
Sponsors
U
UMC Utrecht
Lead Sponsor
A
Alexander Monro Hospital, Bilthoven
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Breast Reconstruction and Neoadjuvant Radiotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 to 75 years
- WHO performance scale 2 or lower
- Able to understand and communicate in Dutch
- Able to understand and sign Dutch written informed consent
- Indication for mastectomy and known need for radiotherapy to at least the chest wall
- May require sentinel node procedure or targeted axillary dissection before surgery to confirm radiotherapy indication
- Specific cancer stages and risk factors as described for nodal involvement and tumor characteristics
You will not qualify if you...
- Legal incapacity
- Unable to understand or sign Dutch written informed consent
- Previous breast cancer or other cancer treated with breast or axillary radiotherapy
- Collagen synthesis disease
- Absolute contraindications to MRI
- Age under 18 years
- Pregnant or breastfeeding
- Smoking
- Body mass index over 35 kg/m2
- Tumor stage cT4 or where skin-sparing mastectomy is not possible
- Certain tumor biology (triple negative or Her2 positive) with no tumor cells in preoperative biopsy after neoadjuvant chemotherapy according to study rules
AI-Screening
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Trial Site Locations
Total: 1 location
1
Maarse Wiesje
Bilthoven, Utrecht, Netherlands, 3722 AG
Actively Recruiting
Research Team
W
Wies Maarse, PhD, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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