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:

• Patients must sign a consent form agreeing to take part in the study.
• Patients must be female and have been diagnosed with a specific type of breast cancer called invasive ductal carcinoma.
• Patients must be considered suitable for breast-conserving surgery (a procedure that removes only part of the breast rather than the whole breast).
• The cancer must not have grown into the skin over the breast or the chest wall underneath, based on scans and/or physical examination.
• The largest measurement of the tumor must be less than 3 cm (just over 1 inch), based on ultrasound imaging.
• The tumor must appear in only one spot in the breast (not spread to multiple areas).
• Patients must be older than 45 years of age.
• The tumor must be visible on a CT scan.
• Patients must have an MRI scan as part of their assessment to help map the tumor and check for any other areas of concern. If other areas of concern are found, they must be biopsied and shown to be cancer-free before treatment can proceed.
• The lymph nodes must show no signs of cancer, based on physical examination and imaging. If a lymph node looks suspicious, it must be biopsied and shown to be cancer-free.
• The cancer must be estrogen-receptor positive (meaning the cancer cells have receptors that respond to the hormone estrogen).
• The cancer must be HER2-negative (meaning the cancer cells do not have high levels of a particular protein called HER2).
• Patients must weigh less than 150 kg (330 lb) due to the weight limit of the imaging equipment used in the trial.
• Patients must be no taller than 6 feet 6 inches, due to equipment size limitations.
• Patients must be able to lie face-down (on their stomach) during treatment.
• The biopsy must show no lymphovascular invasion (meaning the cancer has not been found inside nearby blood or lymph vessels).
• Patients who are already taking hormonal therapy before starting treatment may still be considered — this will be recorded by the trial team.

Who may not be able to join:

• People whose cancer is present in more than one area of the breast (multicentric disease).
• People who have previously had radiation therapy to the affected breast.
• People whose breast size or anatomy makes it impossible to fit into the specialised breast cup used to keep the breast still during treatment.
• People for whom a proper seal cannot be achieved with the immobilisation breast cup.
• People who are male.
• People who have breast implants.
• People who are unable to lie comfortably face-down, for example due to a physical disability.
• People who are planned to have a full breast removal (mastectomy).
• People whose tumor is less than 5 mm from the skin surface or chest wall, based on examination or imaging.
• People whose tumor measures more than 3 cm.
• People with psychiatric conditions or substance-related disorders that would make it difficult to give informed consent or complete the study (confirm with trial site).
• People who are pregnant or breastfeeding, due to the potential effects of radiation.
• People who are unable to have an MRI scan, for example due to a known reaction to contrast dye or other health concerns.
• People whose biopsy showed lymphovascular invasion (cancer found inside nearby blood or lymph vessels).
• People whose cancer is a type other than invasive ductal carcinoma, including invasive lobular carcinoma.
• People whose cancer is estrogen-receptor negative.
• People whose cancer is HER2-positive.
• People with pure ductal carcinoma in situ, which has no invasive component.
• People who weigh more than 330 lb (150 kg).
• People who have previously had breast cancer in the same breast.
• People who have widespread calcium deposits (diffuse calcifications) in the breast shown on a mammogram, classified as BIRADS 3, 4, or 5 (confirm with trial site).

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