Breast Cancer Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Women between 18 and 75 years of age (premenopausal or perimenopausal women must have a negative pregnancy test and use reliable contraception)
• People with a breast cancer diagnosis confirmed by a core needle biopsy, who have had surgery on one breast only
• People whose breast cancer is classified as stage 0 to stage III (based on the 8th edition of the American Joint Commission on Cancer staging system)
• People whose tumour is more than 1 cm away from the nipple and surrounding skin area, based on examination or imaging before surgery
• People whose tumour is 2–3 cm in diameter (or has been reduced to 3 cm or less through pre-surgery chemotherapy), located anywhere in the breast, and where the tumour is at least 8–10 mm away from the skin surface
• People with no clinical or imaging evidence that the tumour has spread to the skin, chest wall, or nipple area
• People who are medically eligible for breast-conserving surgery but have a strong wish for full breast reconstruction instead
• People undergoing preventive (risk-reducing) mastectomy, such as those with BRCA1/2 gene mutations and a significant family history of breast cancer, or others considered high risk (confirm with trial site)
• People with no signs of the cancer having spread to distant parts of the body before surgery
• People with no prior history of breast cancer or other serious underlying health conditions
• People with a general health performance score meeting the trial's minimum thresholds (Karnofsky score of 70 or above, and ECOG score of 2 or below — confirm with trial site)
• People whose planned surgery includes mastectomy (with or without endoscopic assistance), lymph node assessment, and immediate breast reconstruction
• People who are able to understand the study process, are willing to participate and sign consent forms, and are able to attend follow-up appointments
• People with no difficulty swallowing and no restricted movement in the shoulder joint
• People with complete and available medical records

Who may not be able to join:

• Men with breast cancer, or people with inflammatory breast cancer
• People with stage IV (metastatic) breast cancer, or where the tumour has grown into the skin, the main chest muscle, or the nipple area
• People with incomplete medical records
• People who have previously received chemotherapy or had tumour removal surgery at another hospital
• People who have had or need surgery on both breasts
• People whose planned surgery does not match the procedures specified by the trial (confirm with trial site)
• People who have distant spread of cancer before surgery, or who require lymph node removal above the collarbone
• People who currently have, or have had in the past 5 years, another type of cancer in addition to breast cancer
• People with serious non-cancer health conditions that could affect their ability to participate safely or follow the study requirements
• People with dementia, an intellectual disability, or a mental health condition that would prevent them from understanding and signing the consent form

Important: Always verify eligibility with the trial site directly before applying.