Breast reconstruction choices after mastectomy when radiotherapy is planned
Official title: Breast Reconstruction and Radiotherapy: a Nationwide Cohort Study on Care Evaluation and Optimization
Run by Erasmus Medical Center · NCT07178886 · Data updated 2026-11-12
This nationwide prospective effort will compare reconstruction types and timing to see if certain approaches give better satisfaction, fewer complications, and lower costs for adults having mastectomy plus radiotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 750 (estimated) |
| Sponsor | Erasmus Medical Center Academic / other |
| Locations | 1 site (Rotterdam) |
| Status | Recruiting |
| Started | August 22, 2025 |
| Main results expected | August 1, 2027 |
| Study ends | December 31, 2032 |
| Registry record updated | September 17, 2025 |
| Trial ID | NCT07178886 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) with unilateral non-metastatic breast cancer who will have mastectomy and planned adjuvant radiotherapy and who can give informed consent are ideal candidates.
✕Probably not a fit
Patients with prior thoracic radiotherapy, a history of prior breast cancer, metastatic disease, or other excluded malignancies are not eligible and therefore will not benefit from the study's findings directly.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a nationwide prospective observational comparison of different breast reconstruction approaches (implant versus autologous tissue) and their timing in relation to radiotherapy. Adults with unilateral non-metastatic breast cancer who will have mastectomy and adjuvant radiotherapy are enrolled, with exclusions for prior thoracic radiotherapy or prior breast cancer. Investigators will collect patient-reported outcomes, clinical toxicity and complication data, oncological safety metrics, and health-care cost information over follow-up. The goal is to generate evidence to improve shared decision-making and the cost-effectiveness of reconstruction strategies when radiotherapy is part of treatment.
Why it matters
Potential benefit: If successful, the results could help patients and clinicians choose reconstruction approaches and timing that improve satisfaction and reduce complications when radiotherapy is required.
How similar studies have gone: Only a few high-quality prospective comparisons exist; smaller studies have suggested higher complication rates with implants after radiotherapy, but comprehensive nationwide prospective data are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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's running
-
Erasmus Medical Center
Rotterdam, Netherlands Recruiting
Study contacts
- Study coordinator: Janine M Simons, MD PhD
- Email: j.simons@erasmusmc.nl
- Phone: 0031107040521
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.