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 60 or older who have gone through menopause naturally (no periods for 12 or more months, not caused by chemotherapy) or who have had both ovaries surgically removed.
• People with a newly diagnosed invasive breast cancer (ductal, tubular, or mucinous type) where the tumour measures 1 cm or smaller under the microscope, with no sign that cancer has spread to the lymph nodes or elsewhere in the body.
• People whose other (opposite) breast has been assessed by imaging and given a normal or benign rating (BI-RADS 1 or 2).
• People with no cancer found in the underarm (axillary) lymph nodes, confirmed either by a sentinel node biopsy, full lymph node removal, or ultrasound scan (if breast-conserving surgery was performed and no surgical lymph node exploration was done).
• People whose tumour has tested positive for oestrogen receptors (at least 50%) and progesterone receptors (more than 20%), has a low growth rate marker (Ki67 of 15% or less), and is HER2 negative, all assessed according to standard medical guidelines.
• People whose tumour is graded as Grade 1 or 2 (if the tumour is pT1a size) or Grade 1 only (if the tumour is pT1b size).
• People who have been treated with either a full mastectomy or breast-conserving surgery, where the surgeon confirmed that all tumour edges were clear (no cancer cells at the margins).
• People who had breast-conserving surgery and have received, or have a scheduled appointment for, radiation therapy to the breast within 3 months after surgery.
• People for whom adjuvant (post-surgery) chemotherapy is not recommended.
• People who are willing and able to attend scheduled visits, follow tests, and complete all required study procedures for the full duration of the trial.
• People who are registered with a social security or equivalent health coverage system.
• People who have read and signed a written consent form before any trial procedures begin (or, if unable to sign in person, have had their consent confirmed in writing by an independent witness of their choosing).

Who may not be able to join:

• People who have already received any treatment before surgery (neo-adjuvant treatment), including hormone therapy or chemotherapy.
• People who have received, or for whom adjuvant chemotherapy is recommended.
• People who have a medical reason preventing them from receiving radiation therapy, if they had breast-conserving surgery, or people who received partial breast irradiation only.
• People who had a mastectomy and have already received or have radiation therapy planned.
• People diagnosed with invasive lobular breast cancer (a specific cancer cell type).
• People with cancer in both breasts, or a history of invasive breast cancer in either breast.
• People whose cancer is found in more than one area or site within the breast (multifocal or multicentric disease).
• People whose cancer involves only very tiny areas of invasion smaller than 1 mm (microinvasion only).
• People whose cancer shows signs of spreading into nearby blood vessels or lymph vessels (lymphovascular invasion).
• People with a history of cancer other than breast cancer, unless they have been free of that cancer for more than 5 years and it is considered low risk — exceptions may apply for certain treated non-invasive cancers such as cervical, endometrial, or colon carcinoma in situ, melanoma in situ, or certain skin cancers (confirm with trial site).
• People with a serious non-cancer illness that means life expectancy is expected to be less than 10 years.
• People who carry high-risk gene mutations linked to breast cancer, such as BRCA1, BRCA2, or similar variants.
• People who have been enrolled in another treatment trial within the 30 days before joining this trial.
• People who are unable or unwilling to attend the required medical follow-up appointments, for any reason including location, family, social, or personal circumstances.
• People who are under legal custody, protective supervision, or guardianship.

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