Recruiting

Breast Reconstruction and Radiotherapy

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…

ClinicalTrials.gov IDNCT07178886
PhaseNot Applicable
Enrollment750
SponsorJanine M. Simons MD PhD
Age18 Years
SexALL
I'm interested View official listing

Conditions studied

Breast Cancer

About this study

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.

Primary outcomes

Eligibility information

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)

Study locations

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-29.