Phase 4 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 who have given written consent to participate before any trial procedures begin
• People who are willing to attend all required appointments and follow the trial procedures for its full duration
• People who are female and aged 18 or older
• People who have been diagnosed with breast cancer that is hormone receptor positive (HR+) and HER2 negative, meaning the cancer is fuelled by hormones but does not overproduce a certain protein called HER2
• People whose breast cancer shows at least one hormone receptor (estrogen or progesterone) when tested in a laboratory using standard methods
• People whose breast cancer does not show overproduction of the HER2 protein, confirmed by laboratory testing
• People whose cancer has come back locally in a way that cannot be fully treated with surgery or radiation, or whose cancer has spread to other parts of the body (metastatic disease)
• People for whom hormone-based treatment is appropriate for their metastatic cancer
• People whose general health and ability to carry out daily activities falls within an acceptable range on a standard medical scale (ECOG performance status of 0, 1, or 2) (confirm with trial site)
• People who have cancer that has spread to the brain, provided that spread is stable — meaning radiation to the brain was completed more than 14 days ago and only a low dose of steroid medication (no more than 4 mg of Dexamethasone per day) is needed
• People who are either pre- or post-menopausal; women who could become pregnant and whose male partners are potentially fertile must use a highly effective form of contraception throughout the trial and for at least 3 weeks after the last dose of trial drugs, and for 2 years after the last dose of fulvestrant specifically
• People who have not previously received treatment for metastatic disease, except for first-line hormone therapy taken for no more than 3 months before starting the trial drug, provided the cancer did not progress during that time
• People who have previously received hormone therapy or chemotherapy as part of earlier (adjuvant or neoadjuvant) treatment for breast cancer
• People who have recovered from the side effects of prior chemotherapy (side effects must be at a mild or resolved level, except for hair loss or mild nerve-related symptoms), with at least 21 days having passed since the last chemotherapy dose
• People who have fully recovered from any prior radiotherapy, with at least 14 days having passed since treatment ended
• People who have at least one area of cancer that can be measured or assessed using standard imaging methods
• People whose blood counts and organ function (including bone marrow, liver, and kidneys) meet the required levels based on recent blood tests (confirm specific values with trial site)
• People who are able to swallow tablets or capsules
• People who are willing to use a digital health app called CANKADO to report side effects and wellbeing (this is strongly recommended but not required to participate)
• People who test negative for pregnancy before joining the trial, and again within 7 days after the first dose of trial treatment (applies to women who could become pregnant)

Who may not be able to join:

• People whose cancer is causing a life-threatening crisis affecting major organs, or whose life expectancy is less than 6 months
• People who have had an allergic reaction to abemaciclib or any of its ingredients in the past
• People who have previously received chemotherapy or hormone therapy for metastatic disease, except for first-line hormone therapy taken for no more than 3 months before the trial start, provided no progression occurred
• People for whom hormone-based therapy is not considered appropriate by their treating doctor
• People with serious or uncontrolled health conditions, or significant social or mental health difficulties, that could interfere with treatment or with following the trial requirements
• People with serious pre-existing medical conditions that the trial doctor believes would make participation unsafe — examples include certain lung conditions, severe breathing difficulties, severely reduced kidney function, a history of major stomach or bowel surgery, Crohn's disease, ulcerative colitis, or a long-term condition causing ongoing diarrhoea at a moderate or severe level
• People who have previously received a CDK4/6 inhibitor (such as ribociclib or palbociclib) for metastatic or locally advanced disease, unless that treatment was stopped within 3 months due to side effects and the cancer did not progress; prior use of a CDK4/6 inhibitor in earlier (adjuvant or neoadjuvant) treatment is permitted
• People who have taken part in another clinical trial or received an experimental treatment within the past 4 weeks (or within 5 half-lives of that drug, whichever is longer)
• People with a personal history of fainting due to a heart-related cause, dangerous heart rhythm problems, or sudden cardiac arrest
• People who are currently pregnant or breastfeeding
• People who do not have the legal capacity to consent to participate
• People with a history of another cancer (other than certain skin cancers or early cervical cell changes), unless they have been in full remission without any treatment for at least 3 years
• People with an active serious infection — such as a bacterial infection requiring intravenous antibiotics, a fungal infection, or a known active viral infection such as HIV, hepatitis B, or hepatitis C
• People who have received any systemic cancer treatment within the 21 days before starting the trial, except for first-line hormone therapy for metastatic or locally advanced disease
• People who have received radiotherapy within the 14 days before registering for the trial
• People who have had major surgery within the 14 days before registering for the trial

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