Breast Reconstruction and Radiotherapy: a Nationwide Cohort Study on Care Evaluation and Optimization

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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

Locations
Other Locations
Netherlands
Erasmus Medical Center
RECRUITING
Rotterdam
Contact Information
Primary
Janine M Simons, MD PhD
j.simons@erasmusmc.nl
0031107040521
Time Frame
Start Date: 2025-08-22
Estimated Completion Date: 2032-12-31
Participants
Target number of participants: 750
Treatments
All patients, 18 years or older, treated with mastectomy and radiotherapy for breast cancer.
Adult patients with breast cancer (to be) treated with mastectomy who have an indication for radiotherapy and who may or may not undergo breast reconstruction will be included.~The following treatments of interest will be identified:~* immediate breast reconstruction (implant-based or autologous)~* delayed breast reconstruction group (implant-based or autologous)~* no breast reconstruction group
Related Therapeutic Areas
Sponsors
Leads: Janine M. Simons MD PhD
Collaborators: Maastro Clinic, The Netherlands, ZonMw: The Netherlands Organisation for Health Research and Development

This content was sourced from clinicaltrials.gov