Phase 3 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 able to understand the purpose of the study and have signed a written consent form before any study procedures begin.
• People aged 18 or older at the time of signing the consent form.
• Women who are pre- or perimenopausal, or men, who have been receiving a hormone-suppressing injection (LHRH analogue) for at least 28 days before joining the study and plan to continue it throughout — or women who are post-menopausal, defined as being aged 60 or older, having had no periods for at least 12 consecutive months with confirmed post-menopausal hormone levels, or having had both ovaries surgically removed.
• People with a confirmed diagnosis of breast cancer (adenocarcinoma) that has either spread to other parts of the body or cannot be removed by surgery with the aim of curing the disease, confirmed by CT scan or MRI.
• People whose breast cancer tests positive for oestrogen receptors (ER+) and negative for HER2, based on the most recent testing guidelines.
• People whose cancer has been tested for a specific gene change called an ESR1 mutation, using an approved blood or tumour test, before joining the study.
• People whose cancer has shown signs of getting worse while being treated with a specific type of targeted therapy called a CDK4/6 inhibitor combined with hormone therapy — either after at least 6 months of treatment for advanced disease, or after at least 12 months of adjuvant (post-surgery preventive) treatment, provided the cancer worsened no more than 12 months after finishing that adjuvant treatment.
• People who have previously received at least one but no more than two rounds of hormone therapy for advanced breast cancer (progression during or within 12 months of hormone therapy after surgery also counts as one line of treatment).
• People who have not previously received certain specific treatments for advanced disease, including elacestrant, other experimental hormone-blocking drugs (investigational SERDs, PROTACs, CERANs, or novel SERMs), or drugs targeting a specific cell signalling pathway (PI3K/AKT/mTOR inhibitors, including everolimus). A treatment called fulvestrant is allowed if it was completed at least 28 days before joining the study.
• People who have not received chemotherapy for advanced disease.
• People who have at least one area of disease that can be measured or assessed on scans, including bone-only disease with at least one specific type of bone lesion.
• People who are willing and able to provide a tumour tissue sample (either a recently stored sample or a new biopsy if possible).
• People with cholesterol and triglyceride (blood fat) levels within acceptable ranges on fasting blood tests.
• People with blood counts, liver function, kidney function, and blood-clotting results all within acceptable ranges on recent blood tests, without needing recent blood transfusions or certain blood-boosting medications.
• People who have recovered from side effects of previous cancer treatments, with most side effects reduced to a mild level (grade 1 or lower); mild hair thinning (grade 2 alopecia) is allowed.
• Women who could become pregnant and are sexually active with a male partner must have a negative pregnancy blood test within 7 days before joining, and must agree to use a highly effective form of contraception from 28 days before starting treatment until 120 days after the last dose. They must also agree not to donate eggs or breastfeed during this period.
• Male participants with a female partner who could become pregnant must be surgically sterile or use a highly effective form of contraception from 28 days before starting treatment until 120 days after the last dose, and must not donate or bank sperm during this time. Complete abstinence from heterosexual activity for the full study period and 120 days after the last dose is also accepted if that is the participant's usual lifestyle.
• People with a general health and activity level rated as 0 or 1 on a standard medical scale (meaning fully active or able to carry out light activity).
• People with a life expectancy of at least 12 weeks at the time of screening.

Who may not be able to join:

• People who are unable or unwilling to follow the study procedures and attend follow-up visits.
• People whose cancer is causing a serious, urgent crisis in their internal organs or rapidly worsening symptoms in their organs — which would make hormone therapy medically unsuitable.
• People currently taking part in another treatment clinical trial.
• People who have received any approved or experimental cancer treatment within 14 days before joining (or within 28 days if they received fulvestrant).
• People with active or symptomatic cancer that has spread to the brain or the lining of the brain and spine, unless they have already been treated for this, are currently stable, and have been off anti-seizure medications and steroids for at least 14 days before joining.
• People with an intact uterus who have a history of a pre-cancerous uterine lining condition (endometrial intraepithelial neoplasia or higher-grade lesion).
• People who have had another cancer in the past three years, with some exceptions for certain low-risk or early-stage cancers (confirm with trial site).
• People with a known allergy or serious reaction to any of the study medications or their ingredients.
• People with conditions that affect how the body absorbs food or medication through the gut, such as bowel blockages, malabsorption conditions, or a history of gastric bypass surgery — or people who are unable or unwilling to swallow tablets.
• People who have had radiation therapy to a limited area within the past 2 weeks, or to a large area or more than 30% of the bone marrow within the past 4 weeks.
• People who have had a major surgery or serious physical injury within 14 days before joining, or who are expected to need major surgery during the study.
• People with significant heart or blood vessel problems, including recent heart attack, bypass surgery, serious heart failure, unstable chest pain, stroke, or mini-stroke within the past 6 months.
• People with uncontrolled irregular heart rhythm, significant heart rhythm problems (grade 2 or higher), or an abnormally long heart electrical interval on ECG (QTcF greater than 480 milliseconds).
• People with serious lung problems, including very extensive lung spread of cancer, serious underlying lung disease (such as severe asthma, severe COPD, or post-COVID lung scarring), certain autoimmune or inflammatory conditions affecting the lungs, or a history of surgical removal of an entire lung.
• People who have had lung inflammation (ILD/pneumonitis) that was not caused by infection, currently have it, or have suspected lung inflammation that cannot be ruled out by scans at screening.
• People with a history of blood clotting problems (such as deep vein thrombosis or pulmonary embolism) within the past 6 months — though some exceptions apply for well-managed, stable clotting conditions treated with blood thinners (confirm with trial site).
• People currently using immune-suppressing medications or long-term steroid medications, unless the use is limited to topical, inhaled, eye drop, mouthwash, or local injection forms — or unless the person has been on a stable low dose of steroids (10 mg per day or less of prednisone or equivalent) for at least 2 weeks before joining.
• People who are unable or unwilling to avoid certain prescription drugs, over-the-counter medicines, herbal supplements (such as St. John's Wort), or foods (such as grapefruit, pomelos, star fruit, and Seville oranges) that interfere with how the study medication is processed by the body — unless these can be stopped for at least 14 days or five half-lives (whichever is shorter) before joining and for the whole study.
• People who are pregnant, breastfeeding, or unwilling to use effective contraception as required by the study.
• People with a current active infection with HIV, hepatitis B, or hepatitis C (some exceptions apply for people with past resolved infections — confirm with trial site). People with any other active, uncontrolled infection at the time of screening are also excluded.
• People with a known substance use disorder or any severe uncontrolled psychiatric or medical condition that, in the treating doctor's judgement, would make participation unsafe or unsuitable.

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