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 who are willing and able to sign and date a consent form before any study procedures begin (declining the optional genetic or research components will not affect eligibility for the main trial)
• Women aged 18 years or older
• Women who have a biopsy-confirmed diagnosis of breast cancer that has come back, cannot be surgically removed, has spread to nearby tissue, or has spread to other parts of the body (including spread to bones only), and whose cancer has tested negative for HER2neu
• Women whose cancer has been confirmed by biopsy at a site where it has spread, with appropriate hormone receptor and HER2neu testing performed on that sample
• Women whose cancer can be measured or assessed on imaging scans (CT scan of the chest, abdomen, and pelvis with a bone scan, or a PET/CT scan)
• Women whose breast cancer tests positive for androgen receptor (AR) — meaning at least 1% of cancer cells show AR staining on a laboratory test
• People who have a general health status rated 0, 1, or 2 on a standard scale used by doctors (meaning able to carry out normal daily activities with at most moderate limitations), with no worsening in the past 2 weeks, and a life expectancy of at least 12 weeks
• People whose cancer is hormone receptor positive (ER+ or PR+) and who have received at least one prior hormone therapy for the cancer after it spread, with no more than two prior chemotherapy treatments for metastatic disease (prior treatment with CDK4/6 inhibitors such as abemaciclib, palbociclib, or ribociclib is permitted)
• People whose cancer is triple-negative (ER-, PR-, HER2-) and who have received between one and four prior chemotherapy treatments after the cancer spread
• People who have recovered from most side effects of prior chemotherapy (side effects must be mild or resolved, except for hair loss or mild nerve-related symptoms), with at least 21 days passed since the last chemotherapy dose before joining the trial
• People who have fully recovered from any prior radiotherapy, with at least 14 days passed since completing radiation before joining the trial
• Women who are post-menopausal, defined by any one of the following: having had both ovaries surgically removed; being aged 60 or older; or being under 60 with no menstrual periods for 12 or more months and hormone levels in the post-menopausal range (confirm with trial site)
• Women who are not post-menopausal but are receiving ovarian suppression therapy (such as goserelin or leuprolide), provided that therapy was started at least 2 weeks before beginning the study treatment
• Women of childbearing potential who have a negative blood pregnancy test within 7 days before starting treatment
• Women of childbearing potential and male participants who agree to use a highly effective method of contraception throughout the trial and for a set period after finishing (3 weeks for women; 90 days for men), and who agree not to donate sperm or become pregnant during this time

Who may not be able to join:

• People who have taken an experimental drug or participated in another clinical trial within 28 days before the first dose of study treatment
• People who have received chemotherapy, immunotherapy, or other anti-cancer treatment within 21 days before the first dose of study treatment
• People who have previously received anti-androgen therapies such as bicalutamide, abiraterone, or enzalutamide
• People who have had major surgery (not including placement of a drip or port) within 4 weeks before the first dose of study treatment
• People who have cancer that has spread to the spinal cord or the brain, unless it has been treated, is stable, causes no symptoms, and has not required steroid treatment for at least 2 weeks
• People currently taking hormone therapies such as tamoxifen, anastrozole, letrozole, exemestane, or the oral contraceptive pill
• People with severe or uncontrolled serious illnesses, including active uncontrolled bleeding conditions, or active infections such as hepatitis B, hepatitis C, or HIV, as assessed by the study doctor
• People with certain heart-related conditions, including abnormal heart rhythm measurements on an ECG, a history of serious heart rhythm problems, heart failure, a personal history of fainting due to a heart cause, cardiac arrest, or certain heart procedures or events (such as a heart attack, bypass surgery, or angioplasty) within the past 6 months (confirm specific criteria with trial site)
• People with uncontrolled low blood pressure (systolic below 90 mmHg and/or diastolic below 50 mmHg)
• People whose heart pumping function (left ventricular ejection fraction) is below the normal range for the trial site
• People with a previous history of blood clots in the veins or lungs, or a stroke caused by a clot, unless currently taking blood-thinning medication
• People whose blood test results show that bone marrow function, liver function, kidney function, or other organ function is below the levels required for the trial (confirm specific thresholds with trial site)
• People with liver disease such as cirrhosis or chronic active hepatitis (though people with a specific hepatitis B antibody marker may be eligible if they are taking and complying with daily hepatitis B preventive medication)
• People with serious or uncontrolled pre-existing medical conditions that the study doctor believes would make participation unsafe, such as severe lung disease, severe kidney impairment, inflammatory bowel disease, or pre-existing ongoing diarrhoea at a moderate or worse level
• People with severely reduced lung function based on breathing tests, or blood oxygen levels at or below 89% while at rest breathing normal air
• People with uncontrolled diabetes, based on a fasting blood sugar level above 1.5 times the upper limit of normal
• People who have ongoing nausea and vomiting that cannot be controlled, chronic digestive conditions, an inability to swallow tablets, or a history of significant bowel removal surgery that could affect how the study medications are absorbed
• People with an active bleeding disorder
• People with an active bacterial infection requiring intravenous antibiotics, an active fungal infection, or a detectable viral infection such as HIV or active hepatitis B or C at the time of starting the study
• People who have had an allergic reaction to abemaciclib or bicalutamide, or to medications with a similar chemical structure
• People who, in the study doctor's judgement, are unlikely to follow the study procedures and requirements
• People currently taking certain medications that significantly interact with the study drugs, including specific antibiotics, antifungals, antivirals, anti-seizure medications, and some herbal supplements such as St John's Wort (confirm the full list with the trial site)
• People who have had another cancer within the past 3 years, except for certain treated skin cancers or treated cervical cancer
• Women who are pregnant or breastfeeding
• People of reproductive potential who are not using effective contraception (hormonal contraception is not acceptable as the sole method in this trial)

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