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:

• People aged 18 or older
• People who have been diagnosed with breast cancer that has spread to nearby lymph nodes (confirmed by tissue or cell testing), at a stage classified as Stage II or III (all cancer subtypes are accepted)
• People whose lymph node involvement was detected by imaging but could not be felt by hand, and confirmed by a tissue sample
• People whose affected lymph nodes can be felt and have been confirmed by a tissue sample
• People with a hidden breast tumour, provided that cancer in the armpit lymph nodes has been confirmed by biopsy
• People who are eligible for surgery to remove either all armpit lymph nodes or just the sentinel (first) lymph node(s), and who are either newly diagnosed, or have had cancer return in the same breast at least 3 years after previous breast-conserving surgery — with no prior armpit dissection or armpit radiation
• People who are having surgery as the first treatment (before any chemotherapy or radiation)
• People whose most concerning lymph node has been marked with a small metal clip (if this is not routine practice at the trial site, it may be done as part of the study after consent)
• People who are able to complete quality-of-life questionnaires
• People with a general health status rated 0, 1, or 2 on the WHO performance scale (meaning they are fully active to capable of limited self-care)
• People who are in adequate health to safely undergo general anaesthesia, breast cancer surgery, and radiotherapy
• Women who could become pregnant must be using effective contraception, must not be pregnant or breastfeeding, and must agree not to become pregnant during the trial treatment period and for the time recommended by guidelines afterward — a negative pregnancy test is required before registration
• Men must agree not to father a child during trial treatment and for 6 months afterward

Who may not be able to join:

• People with Stage IV breast cancer (cancer that has spread to distant parts of the body)
• People with a specific advanced lymph node classification (clinical N3c) where there is no armpit involvement (note: some other N3 and N2 categories are allowed — confirm with trial site)
• People with a specific lymph node classification called clinical N2b (confirm with trial site)
• People who have had breast cancer on the opposite side within the past 3 years
• People who have previously had surgery to the armpit lymph nodes (except a prior sentinel node procedure in cases of cancer returning in the same breast)
• People who have previously had radiotherapy to the regional lymph node area
• People who have received cancer treatment before surgery, unless it was a short bridging treatment lasting less than 3 months
• People with a history of blood cancer or another solid tumour cancer, unless they have been in remission for at least 3 years — with exceptions for certain localised skin cancers or cervical pre-cancer that has been adequately treated
• People with serious medical, psychiatric, psychological, family, or geographical circumstances that the investigating doctor believes could interfere with treatment, follow-up, or safety
• People (assessed during surgery) in whom the marked clip cannot be found in the removed tissue, in whom visible disease remains in the armpit after the procedure, or in whom no sentinel lymph node is identified in the armpit

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