Phase 2 Endometrial 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 been diagnosed with one of these types of uterine cancer, confirmed by laboratory testing of tissue: uterine leiomyosarcoma (uLMS), endometrial stromal sarcoma (ESS), uterine adenosarcoma, or uterine PEComa.
• People whose tumour tissue shows a moderate to strong presence of estrogen receptors in at least 75% of the tumour cells, as assessed by a pathology laboratory.
• People whose cancer has spread locally or to other parts of the body and cannot be removed by surgery.
• People who have at least one tumour that is large enough to be measured on imaging — at least 2 cm on a chest X-ray, or at least 1 cm on a CT scan, MRI, or physical examination.
• People aged 18 years or older at the time of giving consent.
• People who are reasonably well and able to carry out some daily activities, as measured by a standard health performance scale (ECOG score of 2 or less, or Karnofsky score of 60% or higher).
• People whose blood counts and organ function meet the required levels, including sufficient red blood cells, white blood cells, platelets, and healthy liver and kidney function (confirm specific values with trial site).
• People living with HIV who are on anti-retroviral therapy that does not interact with a specific liver enzyme pathway (non-CYP3A4), and whose virus levels have been undetectable within the past 6 months.
• People with a history of chronic hepatitis B who are on appropriate treatment and whose virus levels are undetectable.
• People with a history of hepatitis C who have been successfully treated and cured, or who are currently being treated and have undetectable virus levels.
• People who have previously had brain metastases, as long as follow-up brain scans after treatment show no sign of the cancer growing.
• People who have been free of any other invasive cancer for more than 5 years, with the exception of certain treated skin cancers or a specific type of treated cervical pre-cancer — and who are not currently receiving treatment for any prior cancer.
• People who have finished prior chemotherapy or radiotherapy more than 2 weeks before joining the study (or more than 6 weeks for certain specific chemotherapy types).
• People who have largely recovered from side effects of prior cancer treatment, with only mild or no remaining side effects (hair loss is an exception and does not need to have resolved).
• People with a history of heart disease or prior treatment with heart-affecting medicines, whose heart function has been assessed and found to be at class 2B or better on a standard heart classification scale.
• People whose heart rhythm measurement (QTc interval) is below 450 milliseconds on an ECG.
• People who are willing and able to follow the study schedule, including attending visits and taking the study treatment as required.
• People who are able to swallow and keep down tablets or pills.
• People who are able to understand the study and are willing to sign a consent form — or, for people with impaired decision-making ability, those who have a legally authorised representative or family member available to provide consent.
• Women who could potentially become pregnant (including those made post-menopausal through the use of GnRH agonist hormone-suppressing injections) must agree to use adequate non-hormonal contraception throughout the treatment period and for at least 6 months after the last dose of the study drug, where there is any risk of conception.
• Acceptable highly effective non-hormonal contraception includes: complete abstinence consistent with the person's usual lifestyle, or a partner who has had a vasectomy (with documentation confirming no sperm present).
• Alternatively, two effective non-hormonal methods used together are acceptable, such as: a non-hormonal intrauterine device (IUD), a condom with spermicide, or a diaphragm or cervical cap with spermicide (confirm specific combination requirements with trial site).
• Women who have not yet reached menopause must have a negative pregnancy test before joining (certain exceptions apply based on age, absence of periods, hormone levels, or surgical history — confirm with trial site).
• Women must meet the trial's definition of being post-menopausal, which includes being aged 60 or over; being under 60 with no periods for 12 or more months and hormone levels in the post-menopausal range; being pre-menopausal but already on a GnRH agonist before starting the study and willing to continue it throughout treatment; or having had both ovaries surgically removed after sufficient recovery time.

Who may not be able to join:

• People who are currently taking part in another clinical trial involving an investigational treatment.
• People who have had a serious allergic reaction to a drug that is chemically similar to the study drug, elacestrant.
• People whose cancer is spreading very rapidly and causing serious symptoms that could become life-threatening in the near future.
• People with uncontrolled ongoing illness, such as an active infection, poorly controlled diabetes, uncontrolled heart disease, or high blood pressure, or any condition that the study doctor believes would make participation unsafe.
• People with a mental health condition or personal circumstances that would make it difficult to follow the study requirements.
• People who have taken strong medicines that affect a specific liver enzyme (CYP3A inducers or inhibitors) within 2 weeks before starting the study treatment, or within five half-lives of that medicine — whichever is longer — if those medicines cannot be replaced (confirm specific medicines with trial site).
• People who are pregnant or currently breastfeeding.

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