Preoperative Radiation Therapy and Immediate Breast Reconstruction
The goal of this phase III randomized controlled trial (PRADAIIBE) is to assess if preoperative radiation therapy (Preop-RT) combined with immediate breast reconstruction (IBR) can safely improve both aesthetic and quality of life outcomes in breast cancer patients, compared to the standard of care (SoC) therapy consis
| Condition(s) | Breast Neoplasms, Breast Carcinoma, Breast Adenocarcinoma, Cancer, Neoplasm |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| Summary | The goal of this phase III randomized controlled trial (PRADAIIBE) is to assess if preoperative radiation therapy (Preop-RT) combined with immediate breast reconstruction (IBR) can safely improve both aesthetic and quality of life outcomes in breast cancer patients, compared to the standard of care (SoC) therapy consisting of post-mastectomy radiation therapy (PMRT) and delayed/immediate breast reconstruction, in a population of breast cancer patients with an indication of mastectomy and PMRT. The following hypotheses and outcomes will be assessed at the primary endpoint of 1 year of follow-up: * Efficacy: Does Preop-RT+IBR lead to a higher BREAST-Q satisfaction with breasts score (primary endpoint), EQ-5D-5L VAS score , EQ-5D-5L Index score, AIS-Total Aesthetic Score, or a shorter treatme |
| Who can participate | Screening assessments, including review of all study eligibility criteria must be completed before enrolment and randomisation. Inclusion criteria: In order to be eligible to participate in this study, a participant must meet all of the following criteria: 1\. Women ≥18 years with histopathologically confirmed breast cancer who: 1.a. require SSM/NSM for any reason (e.g. extensive disease) 1.b. require postoperative radiation therapy of at least the chest wall 1. c. have a wish for a breast reconstruction 2. An Eastern Cooperative Oncology Group (ECOG) performance status grade ≤ 2 3. Participant is able and willing to provide written informed consent, which includes compliance with and ability to undergo all study procedures, and attend the scheduled follow-up visit(s) per protocol. Exclusi |
| Ages | 18 Years |
| Sex | Female |
| Lead sponsor | Cancer Research Antwerp |
| Locations | Edegem, Antwerpen, Belgium; Wilrijk, Antwerpen, Belgium; Brasschaat, Antwerp, Belgium; Namur, Namur, Belgium; Ghent, Oost Vlaanderen, Belgium; Kortrijk, West Vlaanderen, Belgium |
| Start date | 2025-02-20 |
| NCT ID | NCT06739655 |
| Official listing | https://clinicaltrials.gov/study/NCT06739655 |