NCT05216900 Breast Reconstruction and Neoadjuvant Radiotherapy
| NCT ID | NCT05216900 |
| Status | Recruiting |
| Phase | — |
| Sponsor | UMC Utrecht |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2023-04-01 |
| Primary Completion | 2025-12-01 |
Trial Parameters
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Brief Summary
The purpose the BRENAR pilot study is to assess acute post-surgical complications following mastectomy and immediate breast reconstruction after neoadjuvant radiotherapy (NART). The investigators hypothesize that NART will avoid the negative effects of postmastectomy radiotherapy (PMRT) on the capsule of an implant, or on the skin and underlying tissue of an autologous flap, and would therefore lead to better cosmetic results, better quality of life and less complications compared to PMRT. If this hypothesis is confirmed, NART would allow more patients to undergo an immediate reconstruction resulting in superior cosmetic results and quality of life. Furthermore, the use of RT in a neoadjuvant setting could potentially result in a shorter overall loco-regional treatment time from diagnosis to receiving the last locoregional treatment. However, this pilot study will mainly assess whether or not the post-surgical complications of breast reconstruction with NART are acceptable. Further study to investigate long term quality of life and oncologic follow-up results will be conducted after this pilot study, if complication rates are acceptable.
Eligibility Criteria
Inclusion Criteria: * In order to be eligible to participate in this study, a subject must meet all of the following criteria: * Females at least 18 years of age. * WHO performance scale ≤2 * Adequate communication and understanding skills of the Dutch language * Able to understand and sign Dutch written informed consent * Indication for mastectomy and a known indication for (adjuvant) radiotherapy of at least the chestwall. To obtain information on the indication for RT, before the mastectomy is performed, it may be necessary to perform a separate SNP and/or targeted axillary dissection prior to inclusion, i.e. * Stage III (cT3N1, cT0-2N2-3) or cN1 with more than 3 suspicious nodes at initial diagnosis * A positive SN/TAD\* pre- breast surgery in case of: * cT1-2N0 and less than 3 RF\*\* at initial diagnosis and cCR on imaging\*\*\* * cT3N0 and no risk factor at initial diagnosis * If the indication for radiotherapy is not yet clear, and is only indicated when there is a pathological
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