Breast Cancer Trial, Not Yet Recruiting
voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice
Who may and may not 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 may be able to join
- Women between the ages of 18 and 70.
- People who have been diagnosed with breast cancer on one side only, confirmed by a biopsy or tissue test before surgery.
- People who are planned to have a nipple-sparing mastectomy (removal of the breast while keeping the nipple) with an implant placed in front of the chest muscle at the same time.
- People whose breast cancer is either an invasive type with a tumour no larger than 5 cm, or a non-invasive type called ductal carcinoma in situ (DCIS).
- People whose pre-surgery scans show the tumour is at least 1 cm away from the nipple and surrounding dark skin area.
- People where there is no sign that the cancer has spread to the nipple area, the skin, or the chest muscle — the cancer must be contained within the breast tissue.
- People where there is no sign the cancer has spread to other parts of the body.
- People whose lymph nodes do not show signs of cancer based on pre-surgery examination.
- People who have not had chemotherapy or radiotherapy before surgery.
- People who are generally well and able to carry out everyday activities with little to no limitation (confirm with trial site for exact fitness level required).
- People who are willing and able to understand the study, sign a consent form, follow the study procedures, and attend follow-up appointments.
- People whose surgery will be performed by a surgeon who has carried out at least 30 nipple-sparing mastectomies with implant reconstruction.
Who may not be able to join
Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.
- People diagnosed with Paget's disease of the breast, a return of breast cancer after previous treatment, or who have had radiation therapy to the chest area in the past.
- People where the cancer has spread to the skin (including inflammatory breast cancer), the nipple area, or the chest muscle.
- People who are pregnant or breastfeeding at the time of joining the trial.
- People who need further surgery to remove more tissue after a previous breast biopsy, or who have had any prior breast surgery (such as breast enlargement, breast reduction, or partial breast removal).
- People with a breast size larger than a D-cup.
- People with a body mass index (BMI) over 30 (a measure of body weight relative to height).
- People with severe breast drooping where the nipple sits below the natural breast crease.
- People with existing nipple or areola abnormalities (such as inverted nipple or underdeveloped areola), active skin conditions on the breast (such as eczema, skin infection, or ulceration), or significant scarring in the area where surgery would take place.
- People with serious ongoing health conditions such as a weakened immune system, poorly controlled diabetes, severe heart or lung problems, blood clotting disorders, or any condition that makes general anaesthesia unsafe.
- People with a known allergy or sensitivity to silicone implants, or to anaesthetic or antibiotic medicines used around the time of surgery.
- People with pre-existing nerve or neurological conditions (such as nerve damage from diabetes, Parkinson's disease, or spinal cord injury), or who regularly take medicines known to affect nerve or sensory function (such as certain antidepressants or epilepsy medications).
- People who currently smoke more than 20 cigarettes per day.
- People who currently misuse alcohol or are dependent on other substances.
- People who have, or have had, another active cancer diagnosis.
- People who are unlikely to be able to attend follow-up appointments or complete the required post-surgery check-ups.
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
Phone: 13814162016
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
Primary endpoints
Average breast sensory thresholds at 6 months post breast reconstruction as measured by Semmes-Weinstein Monofilaments
Can't join this trial?
Data last synced from ClinicalTrials.gov: 14 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.