Preoperative Radiation Therapy and Immediate Breast Reconstruction
Launched by CANCER RESEARCH ANTWERP · Dec 17, 2024
Trial Information
Current as of August 19, 2025
Recruiting
Keywords
ClinConnect Summary
The PRADAIIBE study is a clinical trial aimed at understanding how the timing of radiation therapy affects breast reconstruction outcomes for women with breast cancer. Specifically, it looks at whether giving radiation before or after surgery to remove the breast tissue leads to better satisfaction with the reconstruction results. Women aged 18 and older, who need a mastectomy (surgical removal of breast tissue) and are planning to have breast reconstruction, may be eligible to participate. Participants must also be in good health, not pregnant or breastfeeding, and able to provide consent for the study.
If you join the trial, you will be randomly assigned to one of two groups. One group will receive the usual care, which involves surgery followed by radiation, while the other group will have radiation before their surgery. Everyone will have follow-up visits at various points over the next ten years to monitor their recovery, answer questionnaires about their satisfaction, and evaluate any side effects. The goal of this study is to improve the quality of life and aesthetic outcomes for women undergoing breast reconstruction after cancer treatment, while also aiming to reduce complications and the overall treatment duration.
Gender
FEMALE
Eligibility criteria
- • Screening assessments, including review of all study eligibility criteria must be completed before enrollment and randomization.
- Inclusion criteria:
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- 1. Women ≥18 years with histopathologically confirmed breast cancer who:
- • 1. require SSM/NSM for any reason (e.g. extensive disease)
- • 2. require postoperative radiotherapy of at least the chest wall
- • 3. have a wish for a breast reconstruction
- • 2. An Eastern Cooperative Oncology Group (ECOG) performance status grade ≤2
- • 3. Subject 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.
- Exclusion criteria:
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- • 1. A previous history of breast cancer or irradiation of the chest wall for any other indication. A bilateral SSM/NSM + reconstruction (e.g. in case of a contralateral prophylactic SSM/NSM) does not fall under this criterium and is thus allowed.
- • 2. Collagen synthesis disease
- • 3. Ongoing pregnancy
- • 4. Actively breastfeeding
- • 5. Smoking at time of inclusion (a history 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 willing to operate the patient using autologous tissue transfer. This generally translates to a smoking cessation of \>3months preoperatively.
- • 6. BMI \> 35 kg/m2
- • 7. cT4d tumour, metastatic disease or any reason making SSM/NSM not indicated
- • NOTE: If neoadjuvant chemotherapy is given, and if the indication for adjuvant systemic treatment is dependent on the presence or absence of a pathological complete tumour response pCR (such as in patients with a triple negative or Her2 positive tumour), centres can choose
- • to exclude these patients,
- • only to include these patients when a non-pCR is proven via a biopsy prior to the start of the RT.
- • to include these patients after the end of neoadjuvant chemotherapy, since earlier studies in partial breast RT showed that pCR rate of preop-RT only, followed by surgery \<6-8 weeks is very low in the general breast cancer population (17 of the 110), whilst it seems to be higher in patients with triple negative (6/8) and Her2 positive (1/1).
- • However, the decision to include or exclude the patients which fall into this category, should be made before the subject is randomized.
About Cancer Research Antwerp
Cancer Research Antwerp is a leading clinical trial sponsor dedicated to advancing oncology through innovative research and development. Based in Antwerp, Belgium, the organization focuses on conducting high-quality clinical trials that aim to improve treatment outcomes for cancer patients. With a commitment to collaboration and scientific excellence, Cancer Research Antwerp engages with a multidisciplinary team of researchers, clinicians, and industry partners to explore novel therapeutic approaches and enhance patient care. Their mission is to translate groundbreaking discoveries into effective interventions, ultimately contributing to the global fight against cancer.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Edegem, Antwerpen, Belgium
Wilrijk, Antwerpen, Belgium
Gent, Oost Vlaanderen, Belgium
Kortrijk, West Vlaanderen, Belgium
Namur, , Belgium
Patients applied
Trial Officials
Melanie Machiels, MD, PhD
Principal Investigator
Iridium Netwerk
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported