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New treatment option for Breast Neoplasms
Official title Preoperative Radiation Therapy and Immediate Breast Reconstruction
ClinicalTrials.gov ID: NCT06739655
What this study is testing
- What it's testing
- 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 treatment duration compared to SoC?
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Screening assessments, including review of all study eligibility criteria must be completed before enrolment and randomisation. In order to be...
- c. have a wish for a breast reconstruction
- An Eastern Cooperative Oncology Group (ECOG) performance status grade ≤ 2
- Participant is able and willing to provide written informed consent, which includes compliance with and ability to undergo all study procedures, and...
You likely can't join if
- A potential participant who meets any of the following criteria will be excluded from participation in this study:
- A previous history of breast cancer or irradiation of the chest wall for any other indication, on the other side (ipsilateral). A bilateral SSM/NSM +...
- Collagen synthesis disease
- Ongoing pregnancy
- Actively breastfeeding
- Smoking at time of inclusion (a history of smoking is allowed but needs to be registered in the eCRF). No interval between smoking cessation and...
See the full eligibility criteria
- Screening assessments, including review of all study eligibility criteria must be completed before enrolment and randomisation. In order to be eligible to participate in this study, a participant must meet all of the...
- c. have a wish for a breast reconstruction
- An Eastern Cooperative Oncology Group (ECOG) performance status grade ≤ 2
- 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.
- A potential participant who meets any of the following criteria will be excluded from participation in this study:
- A previous history of breast cancer or irradiation of the chest wall for any other indication, on the other side (ipsilateral). A bilateral SSM/NSM + reconstruction (e.g. in case of a contralateral prophylactic...
- Collagen synthesis disease
- Ongoing pregnancy
- Actively breastfeeding
- Smoking at time of inclusion (a history of smoking is allowed but needs to be registered in the eCRF). No interval between smoking cessation and study inclusion is defined, but the reconstructive surgeon needs to be...
- BMI \> 35 kg/m2
- cT4d tumour, metastatic disease or any reason making SSM/NSM not indicated
The study team makes the final eligibility decision.
Where it's taking place
- Edegem, Antwerpen, Belgium
- Wilrijk, Antwerpen, Belgium
- Brasschaat, Antwerp, Belgium
- Namur, Namur, Belgium
- Ghent, Oost Vlaanderen, Belgium
- Kortrijk, West Vlaanderen, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Edegem, Antwerpen, Belgium; Wilrijk, Antwerpen, Belgium; Brasschaat, Antwerp, Belgium; Namur, Namur, Belgium; Ghent, Oost Vlaanderen, Belgium; Kortrijk, West Vlaanderen, Belgium. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.