Phase 2 Endometrial Cancer 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 diagnosed with a specific type of uterine cancer — either endometrioid endometrial cancer, or endometrial carcinosarcoma with an endometrioid component — confirmed through a tissue biopsy.
• People whose cancer tests positive for estrogen receptors (ER-positive), meaning at least 1% of cancer cells show estrogen receptor activity on laboratory testing.
• People whose tumor has a normal (wild-type) version of the TP53 gene, confirmed by laboratory testing.
• People whose cancer is classified as "mismatch repair proficient" (MMRp), meaning certain DNA repair proteins are working normally, confirmed by laboratory testing.
• People whose cancer has no known high tumour mutational burden (fewer than 10 mutations per megabase on testing).
• People whose cancer has no known mutations or deletions in a gene called RB1.
• People who have just completed between 4 and 10 cycles of chemotherapy using carboplatin and a taxane drug, or a taxane drug combined with an immune checkpoint therapy (such as pembrolizumab, dostarlimab, or durvalumab).
• People who had stage III, stage IVA, or stage IVB uterine cancer, or cancer that has come back (recurred).
• People who previously received certain treatments, including: adjuvant (preventive) chemotherapy, radiation therapy (completed at least 4 weeks before enrolling), or hormonal therapy for endometrial cancer.
• People who are able to start the study treatment between 3 and 8 weeks after finishing their last dose of chemotherapy (and immune therapy, if applicable).
• People who are considered reasonably functional in daily life, as assessed using a standard medical scale (ECOG performance status of 0–2 — confirm with trial site for details).
• People aged 18 years or older.
• People whose blood counts, liver function, and kidney function fall within acceptable ranges on testing done within 2 weeks before starting treatment (confirm specific values with trial site).
• People who are able to understand the study and are willing to sign a consent form.
• People who are able to swallow and keep down oral (tablet) medication.
• People who are willing to provide stored tissue samples if available.

Who may not be able to join:

• People who have previously been treated with a type of drug called a CDK4/6 inhibitor, including abemaciclib.
• People with digestive system problems that could affect how the body absorbs the study drug — such as bowel obstruction, inability to swallow tablets, malabsorption, or ongoing nausea, vomiting, or diarrhoea above a mild level.
• People who have not yet recovered from the side effects of their chemotherapy (other than hair loss or mild nerve-related symptoms such as tingling or numbness).
• People with an active serious infection requiring intravenous antibiotics, an active fungal infection, or known active HIV, hepatitis B, or hepatitis C.
• People who have had major surgery or a serious injury within 14 days before starting the study, or who have planned major surgery during the treatment period. People who received radiotherapy must have fully recovered from its effects, with at least 14 days between finishing radiotherapy and starting the study.
• People who have had another cancer within the past 3 years, with some exceptions — certain low-risk or fully treated cancers (such as treated cervical carcinoma in situ, basal cell skin cancer, or ductal carcinoma in situ of the breast) may still be eligible (confirm with trial site).
• People with brain metastases (cancer that has spread to the brain) that are not considered stable or adequately treated (confirm specific criteria with trial site).
• People who are pregnant or breastfeeding. People of childbearing potential are required to use an approved contraceptive method during treatment and for 3 months after the last dose, and a negative pregnancy test is required before starting the study.
• People with serious uncontrolled medical conditions that the trial doctor determines would make participation unsafe — examples include certain lung conditions, severe breathing problems, severely reduced kidney function, a history of major stomach or bowel surgery, or pre-existing Crohn's disease, ulcerative colitis, or a chronic condition causing ongoing diarrhoea.
• People who are currently taking certain medications that strongly affect how the body processes the study drug (strong CYP3A4 inducers or inhibitors) — unless a suitable substitute medication can be arranged before starting the trial.
• People with a personal history of fainting due to a heart problem, dangerous heart rhythm problems, or sudden cardiac arrest.
• People with a history of another cancer who have not been disease-free for at least 3 years, unless the treating doctor considers the risk of that cancer returning to be low.

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