Breast Reconstruction and Radiotherapy
Recruiting now
Conditions studied: Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT07178886
- Run by
- Janine M. Simons MD PhD
- People needed
- 750
- Starts
- 2025-08-22
- Expected to finish
- 2032-12-31
- Last updated by the study team
- 2025-09-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 18 years of age or older
- Diagnosed with unilateral non-metastatic breast cancer
- (to be) Treated with mastectomy and to be treated with adjuvant radiotherapy
- Willing and able to provide written informed consent
You may not qualify if…
- History of DCIS or invasive breast cancer
- Previous thoracic radiotherapy treatment
- History of other malignancies (except for patients with basal or squamous cell skin cancer, in situ carcinoma of the cervix and patients who are disease-free at least 5 years following successful treatment for other malignancies)
Where it is running
- Erasmus Medical Center — Rotterdam, Netherlands (enrolling)
Full record on ClinicalTrials.gov
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