Phase 2 Spinal Muscular Atrophy Trial, Recruiting

Written by an AI model from the 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 signed and dated a written consent form before any study procedures begin
• Women aged 18 years or older
• People who have a biopsy-confirmed diagnosis of breast cancer that has come back, cannot be surgically removed, or has spread — and whose cancer tests positive for a protein called the androgen receptor (AR) in at least 1% of cells on laboratory testing
• People whose most recent breast cancer biopsy shows the cancer is triple-negative (low or no estrogen receptor, progesterone receptor, or HER2), based on standard laboratory guidelines
• People whose cancer can be measured on scans, or who have bone-only disease that is getting worse on imaging
• People who are physically well enough to carry out daily activities (as rated on a standard 0–2 scale used by doctors) with no worsening in the past two weeks, and who are expected to live at least 12 weeks
• People who have already received at least one prior cancer treatment for advanced disease — unless the treating doctor considers that type of treatment unsuitable
• People with a known inherited BRCA1/2 gene change who have previously been treated with a type of drug called a PARP inhibitor, unless that treatment was not suitable for them
• People who have had prior treatment with palbociclib or ribociclib, provided at least 6 months have passed since the last dose
• People who have recovered from the side effects of previous cancer treatments to a mild level (with some exceptions for hair loss, anaemia, or nerve-related symptoms), with at least 21 days passed since their last chemotherapy
• People who have fully recovered from any radiotherapy side effects, with at least 14 days passed since radiotherapy ended
• Women who could potentially become pregnant must have a negative pregnancy test within 7 days before starting treatment, and must agree to use a highly effective (non-hormonal) form of contraception during the study and for a set period after treatment ends (3 weeks after one study drug and 130 days after another)

Who may not be able to join:

• People who have taken part in another clinical trial or received an experimental treatment within the past 30 days (or longer, depending on the drug), or who are currently enrolled in another medical research study
• People who have received chemotherapy, immunotherapy, or other cancer treatments within 21 days of the first study dose
• People who have received palbociclib or ribociclib within 6 months of the first study dose
• People who have previously been treated with abemaciclib (one of the study drugs)
• People who have previously been treated with anti-androgen therapies such as bicalutamide, abiraterone, or enzalutamide
• People who have had major surgery (other than placing a medical line for treatment) within 4 weeks before the first study dose
• People who have cancer that has spread to the spinal cord or the lining of the brain, or have active brain metastases — unless the cancer is stable, not causing symptoms, has been treated, and does not require certain steroid medications
• People currently using certain hormone-related medications such as tamoxifen, anastrozole, letrozole, exemestane, or the contraceptive pill
• People with serious or uncontrolled existing health conditions that the treating doctor believes would make participation unsafe — for example, certain lung conditions, severe kidney problems, significant bowel surgery history, or ongoing severe diarrhoea
• People with severe or uncontrolled general health conditions, including active uncontrolled infections such as hepatitis B, hepatitis C, or HIV, or active bleeding disorders
• People with certain heart-related issues, including an abnormal heart rhythm reading on an ECG, a specific type of heart electrical abnormality (QTc interval above 470 milliseconds), heart failure, a history of fainting due to heart causes, dangerous heart rhythm problems, or a history of heart attack, angina, bypass surgery, or related procedures in the past 6 months
• People with uncontrolled low blood pressure
• People with a known low heart pumping function (confirm with trial site)
• People with a prior history of blood clots (deep vein thrombosis or pulmonary embolism) or embolic stroke, unless they are already on blood-thinning medication
• People whose blood test results show the bone marrow, liver, or kidneys are not functioning well enough — including low blood cell counts, or elevated liver or kidney markers above specified levels
• People with certain liver conditions such as cirrhosis or chronic active hepatitis (some exceptions may apply for hepatitis B — confirm with trial site)
• People with severely reduced lung function based on breathing tests, or low blood oxygen levels at rest
• People with uncontrolled diabetes, as shown by a high fasting blood sugar level
• People who have ongoing nausea or vomiting that cannot be controlled, digestive conditions that affect absorption, difficulty swallowing tablets, or who have had significant bowel removal surgery
• People with an active bleeding disorder
• People with an active serious bacterial infection being treated with intravenous antibiotics, an active fungal infection, or a detectable active viral infection
• People with a known allergy or hypersensitivity to any of the study drugs (abemaciclib, bicalutamide, or goserelin) or to similar medicines
• People who the treating doctor believes are unlikely to follow the study procedures and requirements
• People currently taking certain medications that strongly affect how the body processes the study drugs — a specific list of medicines (such as certain antibiotics, antifungals, or anti-seizure drugs) would make participation unsuitable (confirm the full list with the trial site)
• People who have had another cancer in the past 3 years, with the exception of certain treated skin cancers or cervical cancer
• Women who are pregnant or breastfeeding, or women who could become pregnant and are not using an effective non-hormonal method of contraception
• People with certain rare inherited conditions affecting how the body handles a sugar called galactose, or who have total lactase deficiency

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