Phase 2 Breast Cancer Trial, Recruiting

Written by an AI model from the 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 aged 18 or older
• People who have at least one of the following features of their breast cancer: Grade 3 tumour, very low or no estrogen receptor activity (less than 5%), cancer that has spread into nearby blood or lymph vessels, surgical margins less than 2mm, a positive margin on a type of non-invasive cancer called DCIS, a large area of non-invasive cancer within the tumour (extensive intraductal component), age 50 or under, or a tumour larger than 2cm
• People whose breast cancer has been confirmed by a tissue sample (biopsy) and is either invasive breast cancer or Ductal Carcinoma In Situ (DCIS) — a type of early, non-invasive cancer found in the milk ducts
• People whose cancer is classified as stage T0–T3, N0, M0 under standard staging guidelines, meaning the cancer has not spread to lymph nodes or other parts of the body (T0 N0 may be allowed if the treating doctor recommends whole breast radiation)
• People who have had a lumpectomy (surgery to remove the tumour while keeping the breast) within 84 days before starting radiation treatment
• People who are well enough to carry out basic daily activities, as measured by standard medical performance scales (confirm with trial site)
• People whose surgical margins from the lumpectomy were clear of cancer cells, with one exception allowed at a specific deep tissue boundary near the chest muscle
• People who are confirmed not to be pregnant, or who have had permanent surgical sterilisation, or who are post-menopausal (defined as no menstrual periods for 12 months or more, with specific hormone level requirements applying to those under 50)
• People who are sexually active and able to become pregnant who agree to use a highly effective form of contraception during radiation treatment and for 30 days after it ends
• People who are able to understand the study information and willing to sign a consent form

Who may not be able to join:

• People who have cancer in both breasts
• People who have previously had radiation treatment to the chest area
• People who have previously had chemotherapy
• People whose breast cancer has come back after previous treatment
• People who have cancer that has spread to the lymph nodes or to other parts of the body
• People who have had major chest surgery within 8 weeks before starting the study that is expected to affect their ability to take part
• People who have had a previous breast cancer diagnosis in either breast
• People who have another cancer diagnosis that the study doctor considers likely to affect their safety or ability to participate
• People with serious ongoing heart conditions, including severe heart failure, unstable chest pain, or serious irregular heart rhythms
• People who have had a stroke, mini-stroke (TIA), heart attack, or a blood clot (such as a deep vein thrombosis or pulmonary embolism) within the 3 months before starting the study
• People with any other health condition that the study doctor believes would make participation unsafe or too difficult (confirm with trial site)
• People who have had serious complications after their lumpectomy that required an unplanned repeat operation or hospital admission for intravenous antibiotics (note: repeat surgery only to check margins or lymph nodes is generally acceptable)
• People whose breast cancer is a specific rare type known as neuroendocrine carcinoma or sarcoma
• People who have a condition that makes them more sensitive to the effects of radiation, such as certain connective tissue diseases or Li-Fraumeni syndrome
• People with medical, psychiatric, or cognitive conditions that may affect their ability to understand the study, give consent, or follow the study requirements
• People currently taking medications or receiving therapies that increase sensitivity to radiation

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