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:

• Adults (male or female) aged 18 or older at the time of signing the consent form.
• People whose breast cancer got worse while being treated with a CDK4/6 inhibitor combined with an aromatase inhibitor (a hormone-blocking therapy) immediately before joining this trial.
• People with breast cancer that has been confirmed by a biopsy or tissue test to be ER-positive (the cancer responds to oestrogen) and HER2-negative (the cancer does not have high levels of the HER2 protein), and has spread to other parts of the body.
• People whose cancer can be measured on scans according to standard criteria (RECIST 1.1), or whose cancer has spread only to the bones.
• People who are post-menopausal (either due to age, having had both ovaries removed, or having had no periods for at least 12 months for other natural reasons), or who are receiving a medication called a GnRH agonist to suppress ovarian function — with the medication started at least 2 weeks before the first dose of trial treatment.
• People with a general health and activity level rated as 0 or 1 on a standard medical scale (meaning fully active or able to carry out light work).
• People with a life expectancy of at least 6 months.
• People who have recovered from the main side effects of any previous chemotherapy or radiotherapy, with a gap of at least 21 days since the last dose before joining the trial.
• People whose blood tests show the liver, kidneys, and blood cells are functioning at adequate levels as defined by the trial (confirm with trial site for specific values).
• People who are able to swallow oral (tablet/capsule) medication.
• People receiving a GnRH agonist who are willing to use a reliable method of contraception throughout the trial and for 1 year after the last dose of trial treatment.
• People receiving a GnRH agonist who have had a negative pregnancy blood test within 7 days before starting trial treatment.
• People who are willing and able to give written informed consent to take part.

Who may not be able to join:

• People who are currently taking part in another clinical trial or who have received an experimental treatment or used an experimental device within the past 3 weeks.
• People who have had chemotherapy, targeted therapy, or radiation therapy within 2 weeks before starting the trial, or who have not recovered from side effects of a previous treatment.
• People who have had major surgery within 14 days before starting the trial.
• People who have another cancer that is currently growing or requires active treatment (with some exceptions, such as certain treated skin cancers or cervical changes confined to the surface layer).
• People with serious or uncontrolled health conditions that the trial doctor believes would make participation unsafe — for example, certain lung conditions, severe kidney problems, major bowel surgery history, or ongoing bowel diseases such as Crohn's disease or ulcerative colitis.
• People with any condition, treatment, or abnormal test result that the treating doctor believes would interfere with the trial or would not be in the person's best interest.
• People with known psychiatric conditions or substance use problems that would make it difficult to follow the trial requirements.
• People currently taking certain medications that strongly affect how the liver processes drugs (strong CYP3A inhibitors or inducers — confirm with trial site for specific examples).
• People with a known allergy or sensitivity to fulvestrant, abemaciclib, or any of their ingredients.
• People who have problems absorbing medication through the gut due to past surgery, a digestive condition, or an unknown cause.
• People with a bleeding disorder or who are currently taking blood-thinning medications.
• People with active Hepatitis B or Hepatitis C infection.
• People with an active serious bacterial infection requiring intravenous antibiotics, an active fungal infection, or a detectable viral infection such as HIV.
• People with a personal history of certain serious heart conditions, including fainting caused by a heart problem, dangerous heart rhythm problems, or sudden cardiac arrest.
• People with brain metastases (cancer that has spread to the brain) that have not been treated, are causing symptoms, or still require active treatment — although people whose brain metastases were treated at least one month ago and who are now neurologically stable may be considered eligible (confirm with trial site).
• People who have received a live vaccine within 28 days before starting trial treatment.
• People who, within the past 12 months, have experienced fainting due to a heart problem, dangerous heart rhythm problems, or sudden cardiac arrest.
• People who are pregnant or breastfeeding.

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