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:

• People (men or women) diagnosed with breast cancer that has spread to other parts of the body or cannot be surgically removed.
• People whose breast cancer has been confirmed by a tissue sample (biopsy) to be estrogen receptor-positive (ER+) and HER2-negative, and who are considered a candidate for hormone-based treatment — with special rules applying if the biopsy was taken from bone tissue (confirm with trial site).
• People who have gone through menopause, or — if still having periods — have been on a hormone-suppressing injection (GnRH agonist) for at least 6 weeks before the study scan.
• People whose cancer is visible and measurable in at least one location outside the liver, with the affected area measuring 1.5 cm or more.
• People who have received any number of prior hormone-based treatments, and up to one prior chemotherapy, for their advanced cancer — as long as enough time has passed since the last treatment (the required gap varies by treatment type, from 2 weeks up to 16 weeks depending on what was used).
• People whose general health and ability to carry out daily activities meets a standard medical rating of 2 or below on a 5-point scale (confirm with trial site).
• People aged 18 or older.
• People whose blood test results meet minimum levels for white blood cells, platelets, haemoglobin, kidney function, and liver function (specific numbers will be checked by the trial site).
• People who are able and willing to use adequate contraception for the duration of the study.
• People who are willing and able to give written informed consent.
• People who agree to provide stored tumour tissue samples for testing.
• People living with HIV may be eligible, provided their immune cell count is at an acceptable level and they have not had a serious HIV-related infection in the past 12 months (confirm with trial site).

Who may not be able to join:

• People who have previously taken the drug abemaciclib for advanced (metastatic) breast cancer, or who finished a course of abemaciclib as an early-stage treatment within the last 2 years.
• People whose cancer has spread only to the liver, with no other sites of disease.
• People who have had another type of cancer, unless all treatment for that cancer was completed at least 2 years ago and there is no current evidence of that cancer.
• People who are currently taking part in another clinical trial using an experimental treatment.
• People who have brain metastases (cancer that has spread to the brain) that have not yet been treated or are not considered stable — people with treated and stable brain metastases may still be considered eligible.
• People who have had a serious allergic reaction to any ingredient in the study drugs or imaging agents being used.
• People with serious uncontrolled health conditions such as an active infection, heart failure, unstable chest pain, or irregular heart rhythm.
• People who are pregnant or breastfeeding, or people of childbearing potential who do not have a negative pregnancy test within 14 days before starting the study.
• People living with HIV whose immune cell (CD4+) count is below 350 cells/mcL, or who have had a serious HIV-related infection in the 12 months before registration.

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