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 between 18 and 75 years of age (inclusive)
• People with a good general level of physical functioning (low impact from illness on daily activities) (confirm with trial site)
• People whose breast cancer has spread to other parts of the body or has grown into nearby tissue, confirmed by a tissue sample (biopsy)
• Depending on the stage of the trial: people who have previously had at least one hormone-based treatment that stopped working, or people who have not yet received any treatment for advanced disease (confirm with trial site)
• People whose cancer has been confirmed to be growing on scans, or who are currently on a first-line hormone-based treatment for advanced disease with no confirmed progression
• People who have at least one measurable area of cancer outside the brain visible on scans
• People with an expected survival of more than 3 months
• People whose organ function meets the levels required by the trial (confirm with trial site)
• Women who could become pregnant must agree to use highly effective contraception during treatment and for 7 months after treatment ends, must have a negative pregnancy blood test within 7 days before joining, and must not be breastfeeding
• People who are willing to take part, follow all visit schedules and study procedures, and have signed a consent form

Who may not be able to join:

• People who have symptoms caused by cancer that has spread to internal organs
• People whose previous treatment history does not meet the trial's requirements (confirm with trial site)
• People who received certain chemotherapy drugs (nitrosourea or mitomycin) within 6 weeks before the first dose, or who received major surgery, other chemotherapy, immunotherapy, targeted therapy, anti-cancer traditional Chinese medicine, or other trial drugs within 4 weeks before the first dose, or who received hormone therapy or palliative radiotherapy within 2 weeks before the first dose
• People who have recently taken certain medications that interact with a liver enzyme called CYP3A4 within 14 to 28 days before starting the trial (confirm with trial site)
• People with active or symptomatic brain metastases, cancer affecting the membranes around the brain, spinal cord compression, or a history of a primary brain tumour
• People with a history of serious heart or blood vessel disease
• People with cancer-related pain that cannot be controlled
• People who received immune-suppressing medications or high-dose steroid therapy within 2 weeks before the first dose
• People who have not yet recovered from side effects of previous treatments (confirm with trial site)
• People who had a serious infection within 4 weeks before starting the trial
• People who had a blood clot in an artery or vein within 6 months before starting the trial
• People with clinically significant abnormalities of the uterine lining
• People with untreated active hepatitis
• People who have had another cancer within the past 5 years or currently have another cancer
• People with a known tendency to bleed, whether inherited or developed
• People with a history of active autoimmune disease or immune deficiency
• People who have difficulty swallowing or absorbing oral medications (confirm with trial site)
• People with an active infection or active tuberculosis requiring treatment
• People with a known allergy to the trial drugs HRS-8080 or Dalpiciclib, or any of their ingredients
• Women who are pregnant, breastfeeding, or planning to become pregnant during the study
• People with a significant history of neurological or psychiatric conditions, or a history of substance or drug misuse
• People with other serious physical or mental health conditions, or abnormal laboratory results, that the trial doctors consider would make participation unsafe or affect the results

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