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:

• People who have no medical reasons preventing them from having an MRI scan as part of their radiotherapy planning and treatment.
• People whose lumpectomy cavity (the area where breast tissue was removed) is clearly visible on both CT and MRI scans before radiotherapy begins.
• Women who are not pregnant at the time of joining (a pregnancy test will be required for women who could potentially become pregnant).
• People who are willing to sign an approved consent form agreeing to take part in the study.
• People who have had a cancer other than breast cancer may still be considered, provided they have been cancer-free for 5 or more years and their doctor considers them at low risk of that cancer returning. People diagnosed and treated within the past 5 years for certain early-stage or skin cancers (such as early cervical cancer, early colon cancer, melanoma in situ, basal cell carcinoma, or squamous cell carcinoma of the skin) may also be considered.
• For people with invasive breast cancer, those aged 50 or over with clear surgical margins of at least 2 mm and an early-stage tumour (Tis or T1) may be considered under the "suitable" category.
• For people with invasive breast cancer, those aged 40–49 with clear surgical margins of at least 2 mm and an early-stage tumour may be considered under a "cautionary" category (confirm with trial site).
• For people with invasive breast cancer aged 50 or over, those who have at least one specific pathological feature — such as a tumour size of 2.1–3.0 cm, close surgical margins, certain tumour characteristics, or specific tumour types — may be considered under a "cautionary" category, provided no exclusion factors apply (confirm with trial site).
• For people with DCIS (ductal carcinoma in situ, a non-invasive form of breast cancer), those whose cancer was screen-detected, is low to intermediate grade, measures 2.5 cm or less, and was removed with margins of at least 3 mm may be considered under the "suitable" category.
• For people with pure DCIS measuring 3 cm or less who do not fully meet the "suitable" criteria above, consideration under a "cautionary" category may be possible (confirm with trial site).

Who may not be able to join:

• Men are not eligible for this trial.
• People who have tested positive for a BRCA1 or BRCA2 gene mutation.
• People under the age of 40.
• People whose surgical margins were found to contain cancer cells after their operation.
• People with lymph nodes in the armpit or surrounding areas that appear suspicious on examination or imaging, unless testing has confirmed those nodes are free of cancer.
• People with suspicious calcium deposits, dense areas, or lumps in either breast that have not been tested and confirmed as non-cancerous.
• People whose breast cancer is a rare non-epithelial type, such as sarcoma or lymphoma.
• People with cancer that has been confirmed in more than one separate area of the breast (multicentric carcinoma).
• People with pure DCIS larger than 3 cm.
• People with a large area of intraductal cancer spread measuring more than 30 mm.
• People with Paget's disease of the nipple (a rare form of breast cancer affecting the nipple area).
• People with a history of previous invasive breast cancer, DCIS, or breast cancer in both breasts at the same time. (People with a history of LCIS — lobular carcinoma in situ — treated by surgery alone may still be considered.)
• People whose surgical margins could not be properly assessed under a microscope, or were found to be positive for cancer.
• People currently taking hormonal medications such as tamoxifen, raloxifene, aromatase inhibitors, or similar drugs, whether for bone health, cancer prevention, or pre-surgery treatment.
• People who have breast implants.
• People who have previously had radiotherapy to the breast or chest area, or whose treatment plan includes radiotherapy to surrounding lymph node regions.
• People with certain connective tissue or autoimmune conditions, specifically dermatomyositis (with abnormal blood levels or active skin rash), systemic lupus erythematosus, or scleroderma.
• People who are pregnant or breastfeeding at the time of treatment. Women who could become pregnant must agree to use an effective non-hormonal form of contraception during the study.
• People with psychiatric conditions, addiction, or other circumstances that, in the opinion of the research team, would make it difficult for them to meet the study requirements.

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