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 18 years of age or older at the time of screening
• People with breast cancer that cannot be removed by surgery, or that has spread to other parts of the body, and whose cancer tests show it is hormone receptor-positive and HER2 IHC 0 (a specific tumour profile determined by laboratory testing)
• People whose cancer has continued to grow despite hormone-based treatments, and who are not considered suitable for further hormone therapy by their doctor
• People who are generally well enough to carry out everyday activities with little or no limitation (assessed using a standard medical scale called ECOG, scores 0 or 1), with no worsening in the two weeks before starting the trial
• People with a life expectancy of at least 12 weeks at the time of screening
• People who can provide a recent tumour tissue sample (taken no more than 6 weeks before the first dose)
• People whose cancer can be measured or assessed using standard imaging methods
• People whose blood tests show their bone marrow, liver, kidneys, and other organs are functioning at an adequate level within 7 days before starting the trial (specific blood count and organ function values will be checked)
• People of any gender identity, sex assigned at birth, race, or ethnic background
• People who are able to use appropriate contraception during the trial and for a set period after the last dose (requirements differ depending on sex assigned at birth — confirm specific requirements with the trial site)
• People who are willing and able to give informed consent and follow the trial procedures

Who may not be able to join:

• People with serious uncontrolled illnesses, active bleeding conditions, significant heart or mental health conditions, a history of organ transplant from a donor, or substance misuse, where the treating doctor considers participation unsafe
• People with a history of another cancer, unless it was treated with the aim of cure, has shown no signs of return for at least 3 years, and carries a low risk of coming back (some skin cancers and certain treated pre-cancerous conditions may be exceptions)
• People who still have significant side effects from previous cancer treatments (above a mild level), with some exceptions for certain stable, long-lasting side effects as assessed by the treating doctor
• People with cancer that has spread to the spinal cord or brain, unless those areas are stable, causing no symptoms, and have not required steroid or anti-seizure medication for at least 2 weeks before starting the trial
• People with cancer that has spread to the membranes surrounding the brain or spinal cord
• People with significant fluid build-up in body cavities (such as the abdomen or around the lungs) that cannot be drained as needed
• People with significant eye or corneal disease
• People with active or uncontrolled hepatitis B or C infection (some people with treated or managed hepatitis B or C may still be eligible — confirm with trial site)
• People with HIV infection that is not well controlled (those with well-controlled HIV meeting specific medical criteria may be considered — confirm with trial site)
• People with an active infection currently requiring treatment through a drip (intravenous antibiotics, antivirals, or antifungals), or a suspected unresolved infection
• People with known active tuberculosis
• People with abnormal heart electrical activity findings on a resting ECG
• People with serious or uncontrolled heart disease, including a recent heart attack (within 6 months), unstable chest pain, moderate to severe heart failure, uncontrolled high blood pressure, or certain uncontrolled heart rhythm problems
• People who have had inflammation of the lungs (not caused by infection) in the past that required steroid treatment, or who currently have or are suspected to have this condition
• People with severely reduced lung function
• People who have previously received treatment targeting a protein called TROP2, a type of chemotherapy that targets an enzyme called topoisomerase I (including certain antibody-drug combinations), or any chemotherapy for metastatic (spread) breast cancer
• People who have recently taken chloroquine or hydroxychloroquine without allowing at least 14 days to pass before starting the trial
• People who received their last cancer treatment within 3 weeks before starting the trial (or within 2 weeks or 5 half-lives for certain tablet-form targeted therapies, whichever is longer)
• People currently receiving other cancer treatments, with the exception of certain bone-protecting medications (bisphosphonates or denosumab)
• People who received radiation therapy to the chest within 4 weeks before starting the trial, or who still have radiation-related side effects requiring steroids
• People who received recent radiotherapy — within 2 weeks for limited-area palliative radiation, or within 4 weeks for radiation covering a large area of the chest or bone marrow
• People currently taking ongoing high-dose steroid tablets or other immune-suppressing medications (above a low threshold), except for managing treatment side effects (inhaled or topical steroids are generally permitted)
• People who have had major surgery or a serious injury within 3 weeks before starting the trial, or who are expected to need major surgery during the trial
• People who are currently taking part in another clinical trial involving an experimental treatment, or who have previously been enrolled in a study of the drug used in this trial (Dato-DXd)
• People with a known history of severe allergic reactions to Dato-DXd or its ingredients (including polysorbate 80)
• People with a known history of severe allergic reactions to other monoclonal antibody treatments
• People involved in planning or running this study
• People who the treating doctor believes are unlikely to follow the trial requirements
• People who have previously taken part in this specific trial
• People who are pregnant, breastfeeding, or planning to become pregnant (applies to female participants)
• Female participants who are breastfeeding or planning to breastfeed during the trial or for at least 7 months after the last dose
• People for whom the use of a steroid-containing mouthwash is not medically appropriate

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