Preoperative Radiation Therapy and Immediate Breast Reconstruction

Launched by CANCER RESEARCH ANTWERP · Dec 17, 2024

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 for any reason (e.g. extensive disease)
• • 2. require adjuvant radiation therapy 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 not pregnant or breastfeeding
• • 4. 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 another malignancy for which radiation therapy of the breast or axilla was performed.
• • 2. Collagen synthesis disease
• • 3. Contraindications for an MRI (as defined by the local Radiology Department)
• • 4. Smoking at time of surgery (previous smoking is allowed but needs to be registered in the eCRF)
• • 5. BMI \> 35 kg/m2
• • 6. cT4d tumor or any reason making SSM not possible
• • 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 tumor response pCR (such as in patients with a triple negative or Her2 positive tumor), centers 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.