Phase 2 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:

• Women aged 18 or older
• People with a newly diagnosed breast cancer that is ER-positive and HER2-negative, confirmed by tissue biopsy, with a Ki-67 score of 10% or higher (Ki-67 is a marker of how fast cancer cells are growing)
• People who have a planned surgery to remove the breast cancer
• People whose cancer can be detected and measured by mammogram or breast ultrasound, and is larger than 5mm in size (tumours in a previously treated radiation area or those only detectable by physical examination do not count)
• People who are post-menopausal, defined as: last menstrual period more than 12 months ago, or both ovaries removed, or specific hormone blood test results showing FSH above 20 mIU/mL and estradiol at or below 20 pg/mL
• People who are not currently taking an aromatase inhibitor or a selective estrogen receptor modifier (certain hormone-blocking medications)
• People with a general health/activity level rated as 0, 1, or 2 on a standard medical scale (confirm with trial site), assessed within the past 90 days
• People whose recent blood tests (taken within the past 90 days) show healthy enough levels of platelets, white blood cells, haemoglobin, liver enzymes, and kidney function
• People who are willing and able to sign a consent form
• People who are able to complete a symptom diary, either on their own or with help

Who may not be able to join:

• People whose Ki-67 score is below 10%
• People who are currently using any medicinal mushroom products
• People with locally advanced breast cancer requiring chemotherapy before surgery, or cancer that has spread to other parts of the body
• People currently receiving chemotherapy
• People currently taking hormone-blocking medications such as aromatase inhibitors or selective estrogen receptor modifiers
• People with a known allergy to mushrooms
• People with serious other health conditions that, in the doctor's judgement, would make participation unsafe or affect the reliability of the results
• People with a weakened immune system
• People who are HIV positive and currently receiving antiviral treatment (note: people who are HIV positive but show no signs of a weakened immune system may still be considered eligible — confirm with trial site)
• People with certain uncontrolled ongoing health conditions, including active infection, heart failure with symptoms, unstable chest pain, irregular heart rhythm, or mental health or personal circumstances that would make it difficult to follow the study requirements
• People currently taking part in another clinical trial that involves a treatment for their cancer
• People who have had another cancer in the past 3 years (exceptions include certain non-melanoma skin cancers and early-stage cervical changes; people with a prior cancer history must not currently be receiving chemotherapy for that cancer)

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