Phase 3 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:

• The patient or their legal representative must agree to take part and sign a consent form before joining.
• People who are fairly active and able to carry out daily activities with little or no limitation (confirm with trial site for specific fitness level required).
• People who have had a lumpectomy (surgery to remove the tumour while keeping the breast) where the tissue removed showed no cancer cells at the edges.
• People whose breast cancer is a specific type called invasive adenocarcinoma, affecting one breast only.
• People who have had their underarm lymph nodes checked for cancer spread, either through a sentinel node biopsy or full lymph node removal.
• People whose tumour measured 2 cm or smaller based on laboratory examination after surgery.
• People whose lymph nodes showed no cancer when examined after surgery (a specific type of node result — confirm with trial site).
• People whose tumour has a specific genetic test score (Oncotype DX Recurrence Score) of 18 or lower, tested on a biopsy or surgically removed sample. In some cases, a MammaPrint test result in the "Low" category may be accepted instead.
• People whose tumour tested positive for hormone receptors (oestrogen and/or progesterone), meaning at least 1% of tumour cells showed positive staining.
• People whose tumour tested negative for the HER2 protein.
• People who are either pre-menopausal or post-menopausal at the time of joining (specific definitions apply — confirm with trial site).
• People who are joining within 70 days of their last breast cancer surgery.
• People who have fully recovered from surgery, with the wound healed and no signs of infection.
• People who have had a mammogram or breast MRI within the 6 months before joining.
• People living with HIV who are on effective treatment and have had an undetectable viral load within the past 6 months.
• People who plan to take hormone-blocking therapy (endocrine therapy such as tamoxifen or an aromatase inhibitor) for at least 5 years.

Who may not be able to join:

• People with clear signs of cancer that has spread to other parts of the body.
• People whose tumour was very small (pT1mi) or larger than 2 cm, or who have inflammatory breast cancer.
• People whose lymph node results showed any trace or definite spread of cancer.
• People who had a mastectomy (full breast removal) instead of a lumpectomy.
• People with swollen or suspicious lymph nodes in the armpit or nearby areas, unless a biopsy has confirmed they are cancer-free.
• People with suspicious findings on a mammogram or physical examination in either breast, unless a biopsy showed they are not cancer.
• People with rare non-glandular breast cancers such as sarcoma or lymphoma.
• People with cancer in more than one area of the breast, if the areas are in different quarters of the breast or more than 4 cm apart.
• People with Paget's disease of the nipple (a rare type of breast cancer affecting the nipple area).
• People with a previous or current history of invasive breast cancer or a specific pre-cancer type (DCIS) in the same breast.
• People with a previous or current history of invasive breast cancer or DCIS in the opposite breast.
• People whose surgical margins could not be properly assessed or were found to still contain cancer after surgery (unless a further operation successfully cleared the margins).
• People whose treatment plan includes radiation to the lymph node regions.
• People who have already received radiation, chemotherapy, or biological therapy for this current breast cancer diagnosis before joining the trial.
• People who have had another cancer (other than certain skin cancers or localised in-situ cancers removed by minor surgery) within the past 5 years.
• People currently taking hormone-related medications such as tamoxifen, raloxifene, or similar drugs for osteoporosis or cancer prevention (some exceptions may apply — confirm with trial site).
• People who plan to continue using oestrogen-based hormone replacement therapy (in any form — tablet, patch, or implant). People who stopped these before joining may be eligible.
• People who have previously had radiation therapy to the breast or chest area for any reason.
• People with certain active autoimmune or connective tissue diseases, such as lupus, scleroderma, or dermatomyositis with specific lab findings or an active rash.
• People who are pregnant, breastfeeding, or planning to become pregnant during the trial period.
• People with any other serious medical condition, abnormal test result, or health issue that the trial team believes would make participation unsafe or affect the trial results.
• People with psychiatric conditions or substance use disorders that, in the opinion of the treating doctor, would prevent them from meeting the trial's requirements.
• People who have taken part in another clinical trial using an experimental treatment within the 30 days before joining.

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