Actively Recruiting
Breast Reconstruction and Radiotherapy
Led by Janine M. Simons MD PhD · Updated on 2025-09-17
750
Participants Needed
1
Research Sites
384 weeks
Total Duration
On this page
Sponsors
J
Janine M. Simons MD PhD
Lead Sponsor
Z
ZonMw: The Netherlands Organisation for Health Research and Development
Collaborating Sponsor
AI-Summary
What this Trial Is About
If the whole breast is removed because of breast cancer, several options for breast reconstruction are available. All these options have an increased complication risk if a patient has been or will be treated with radiotherapy. However, only a few high-quality studies addressed patient satisfaction and complication risks, both in terms of timing (prior to or after irradiation) and type of reconstruction (implant or own tissue). As radiotherapy indications expand and more patients desire a reconstruction, this is a progressively relevant issue. Through this nationwide prospective study, the investigators aim to identify the most ideal treatment strategy by comparing different reconstruction options in terms of patient reported outcomes (PROs), toxicity, oncological safety and costs. These results will enable improvement of shared decision-making and cost-effectiveness of breast reconstruction strategies in case of radiotherapy.
CONDITIONS
Official Title
Breast Reconstruction and Radiotherapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Diagnosed with unilateral non-metastatic breast cancer
- Undergoing or scheduled for mastectomy and adjuvant radiotherapy
- Willing and able to provide written informed consent
You will not qualify if you...
- History of ductal carcinoma in situ (DCIS) or invasive breast cancer
- Previous thoracic radiotherapy treatment
- History of other malignancies except basal or squamous cell skin cancer, in situ carcinoma of the cervix, or other malignancies disease-free for at least 5 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Erasmus Medical Center
Rotterdam, Netherlands
Actively Recruiting
Research Team
J
Janine M Simons, MD PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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