Breast Cancer Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People who are biologically female and between 18 and 75 years old
- People who have a medical reason for a nipple-sparing or skin-sparing mastectomy, such as early breast cancer or a high-risk genetic condition like a BRCA gene mutation
- People whose physical characteristics make them suitable for a specific type of breast reconstruction (called prepectoral reconstruction), including having adequate skin thickness, healthy blood flow to the skin, a body mass index under 35, and no significant history of chest radiation therapy
- People whose overall health is assessed as suitable for general anesthesia, based on a standard medical classification system (ASA class I to III) (confirm with trial site)
- People who meet the criteria for same-day surgery — including having enough independence at home, a caregiver available for the first 24 hours after surgery, and living close enough to the hospital for safe home recovery
- People who are able and willing to attend follow-up appointments by video or phone and complete required questionnaires about their experience
- People who have given written consent to participate
Who may not be able to join:
- People who regularly use opioid medications or are being treated for long-term chronic pain, as this could affect how pain after surgery is measured
- People who cannot receive certain types of local or regional anaesthesia — for example, due to an allergy to local anaesthetic medicines, a blood clotting disorder, or difficulty cooperating during a procedure performed while awake
- People with a body mass index of 35 or above, or whose anatomy is not suitable for prepectoral reconstruction
- People who have previously had high-dose radiation therapy to the chest that has significantly affected the tissue in that area
- People who are pregnant or breastfeeding
- People who are unable to commit to the planned follow-up schedule or who do not have adequate support at home
- People with a psychiatric or cognitive condition that would prevent them from accurately completing the required questionnaires
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Gianluca Vanni, Associate Professor, University of Rome Tor Vergata
Phone: +393395685883
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Postoperative pain at rest over 48 hours; Major Postoperative Safety Composite at 30 days
Can't join this trial?
Data last synced from ClinicalTrials.gov: 7 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.