Breast Reconstruction and Radiotherapy
Recruiting · NCT07178886 · Observational (researchers observe without assigning treatment) · Lead sponsor: Janine M. Simons MD PhD
View the official record on ClinicalTrials.gov →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.
Who can take part
Inclusion criteria
- 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
Exclusion criteria
- 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
1 location listed.
- Erasmus Medical Center - Rotterdam, Netherlands