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 who are postmenopausal, or pre/peri-menopausal women who have had their ovaries surgically removed or are receiving hormone-suppressing injections
• People who are well enough to carry out basic daily activities (based on a standard health performance scale, scoring below 3 out of 4)
• People whose breast cancer has been confirmed by a tissue biopsy as a "Luminal A" or "Luminal B" type
• People whose breast cancer tests positive for estrogen receptors (more than 1% ER positive)
• People whose breast cancer tests negative for the HER2 protein (confirmed by standard laboratory testing)
• People whose cancer is at an advanced stage (clinical stage IIIb or IV)
• People who either have newly diagnosed advanced breast cancer with no prior systemic treatment for the advanced disease, or whose cancer returned more than 2 years into hormone therapy, or within or after 12 months of completing adjuvant hormone therapy
• People whose cancer can be measured or assessed on scans or other evaluations
• People whose blood counts meet minimum levels — including white blood cells, platelets, and red blood cells — as confirmed by recent blood tests
• People whose liver function blood test results are within an acceptable range
• People whose kidney function is within an acceptable range based on blood tests
• People whose blood calcium level is at or above the normal lower limit
• Women of childbearing potential who have a negative pregnancy test within 7 days before joining, and who agree to use non-hormonal contraception during the study
• People who have tested negative for HIV, Hepatitis B, and Hepatitis C

Who may not be able to join:

• Male patients
• People whose breast cancer is HER2 positive, or whose hormone receptor or HER2 status is unknown
• People with triple-negative breast cancer (estrogen receptor level below 1%)
• People who are currently pregnant, breastfeeding, or planning to become pregnant within 6 months after treatment ends
• People who are unwilling to use highly effective contraception during treatment and for 6 months afterward
• People with any type of breast cancer not described in the inclusion criteria, particularly inflammatory breast cancer or earlier-stage disease (stages I, II, or IIIa)
• People whose cancer cannot be assessed or measured
• People with cancer affecting both breasts
• People with a history of another cancer, except for certain cancers considered fully cured (such as cervical cancer in situ or a type of skin cancer called basal cell carcinoma)
• People with another serious illness considered incompatible with joining this trial (confirm with trial site)
• People with significant heart, kidney, bone marrow, breathing, or liver problems — including recent heart attack, unstable chest pain, serious heart rhythm problems, a history of lung inflammation or scarring, active urinary tract infection, or ongoing bladder bleeding
• People with uncontrolled diabetes
• People with active or worsening brain or central nervous system problems at the time of joining
• People who have tested positive for HIV, Hepatitis B, or Hepatitis C
• People with significant psychiatric conditions
• People with a known allergy or sensitivity to the study treatment or its ingredients
• People with a known history of misuse of narcotic drugs, other medications, or alcohol
• People who have taken part in another clinical trial or received an experimental treatment within 30 days before starting this study
• People who are unable or unwilling to follow the requirements of the study

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