Phase 2 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:

• Adults aged 18 or older
• People who are having underarm (axillary) lymph node removal surgery, with or without lymphatic reconstruction, as part of their breast cancer diagnosis and treatment
• People who have had a special dye-based imaging procedure (called ICG lymphatic mapping) done before their lymph node removal surgery
• People diagnosed with breast cancer ranging from very early stage to more advanced stages (stage Tis through T4, with or without lymph node involvement, but without distant spread — confirm with trial site if unsure of your stage)
• People who are generally well enough to carry out light daily activities (a level of physical fitness measured by a standard medical scale called ECOG 0–1)
• People who have only one active cancer at the time of joining the trial (people with a past or additional cancer may still be considered, but only if the treating doctor and study leader agree it would not affect the trial)
• People who have given written agreement to take part and follow all study procedures
• People who could become pregnant must have a negative pregnancy test before joining and must use a reliable method of contraception throughout the study
• People who have had a physical therapy assessment before their lymph node removal surgery
• People who received chemotherapy before surgery (neoadjuvant chemotherapy) must have had a physical therapy lymphedema assessment after completing chemotherapy and before surgery

Who may not be able to join:

• People with a history of breast cancer (including non-invasive types) on the same side being treated
• People who have previously had surgery in the underarm area on the same side, such as lymph node removal or treatment for certain skin conditions affecting that area
• People with a history of, or a current diagnosis of, breast cancer on the opposite side (both breasts affected)
• People who have had, or are planned to have, underarm surgery on the opposite side
• People with a history of, or current, cancer affecting the arm on the same side as the breast being treated (for example, skin cancer on that arm)
• People who have had lymphedema (swelling caused by lymph fluid build-up) or lymphatic flow problems in either arm, or who are found to have lymphatic problems at their pre-surgery appointment
• People with a history of blood clots in the upper arm or infections of the lymph vessels or skin (such as lymphangitis or cellulitis)
• People with a history of heart failure or significant heart disease, including those with certain types of pacemakers that are not compatible with a body fluid measurement test used in this study
• People with evidence of serious liver disease or liver failure
• People from whom fewer than 10 lymph nodes were removed (or fewer than 8 if they received chemotherapy before surgery), including any nodes removed during a sentinel lymph node biopsy
• People for whom there is no detailed surgical record of what was found and done during the lymph node removal operation
• People who are confirmed to be pregnant or breastfeeding
• People with any other medical condition, test result, or finding that the treating doctor believes could interfere with the study or pose a significant health risk
• People who are prisoners, involuntarily detained, or held in a facility for psychiatric or medical treatment against their will

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