Phase 2 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 what the study involves and can give written consent freely, and who have enough mental clarity to follow the study requirements, including using digital health apps and devices.
• Adults aged 18 or older at the time of signing the consent form.
• People whose general physical functioning is rated at a level where they are fully active, have some limitations but can care for themselves, or are up and about more than half of waking hours (confirm with trial site for exact rating scale).
• People diagnosed with a type of breast cancer that is HER2-positive (either hormone receptor-positive or hormone receptor-negative), confirmed by laboratory testing from a tumour sample taken during the metastatic stage, where the cancer has spread and cannot be removed by surgery or treated with curative radiation.
• People who have not previously received chemotherapy or HER2-targeted treatment for advanced or metastatic breast cancer — though one prior hormone therapy for metastatic disease is allowed, and prior chemotherapy or HER2-targeted therapy given before or after initial surgery is permitted.
• People who received a specific type of antibody-drug therapy (containing an exatecan derivative) after surgery, provided it has been at least 12 months since the last dose.
• People whose cancer can be measured or evaluated according to standard imaging criteria.
• People who can provide an adequate tumour tissue sample from the metastatic setting for laboratory testing.
• People with brain metastases may be eligible in certain circumstances — for example, if the brain tumours have not been treated or have already been treated and do not currently require immediate local treatment, and if the person does not need high doses of steroid medication for symptom control (confirm with trial site for full details).
• People whose blood counts and organ function (such as liver and kidneys) meet the required laboratory thresholds set out in the study protocol.
• People whose heart pumping function (left ventricular ejection fraction) is 50% or above, measured within 28 days before starting the study.
• People expected to live for at least 12 weeks at the time of screening.
• People who have completed the required waiting period since their last cancer treatment before joining the study.
• Male participants and females who could become pregnant who agree to use highly effective contraception methods as specified in the study protocol during the trial.
• People who own or have access to a smartphone with internet connection capable of running the required study apps (Android 8.0 or newer, or iOS 15.0 or newer for one app; Android 13.0 or newer, or iOS 17.0 or newer for another app).
• In France only: people who are enrolled in the French social security system.

Who may not be able to join:

• People whose breast cancer has been confirmed as HER2-negative.
• People who, in the medical team's view, would have difficulty following the study requirements, or who have other health conditions or circumstances that could interfere with participation — including not being able to read or understand the local language used at the study site well enough to interact with study materials and digital tools.
• People with a history of a different type of cancer, unless it was treated with curative intent, shows no signs of active disease within the 3 years before joining, and carries a low risk of returning — with certain exceptions for specific low-risk skin and gynaecological cancers (confirm with trial site).
• People still experiencing side effects from previous cancer treatments (other than hair loss) that have not resolved to a mild level or returned to their baseline health state — with some exceptions for stable or irreversible side effects at the investigator's discretion.
• People with untreated spinal cord compression.
• People with a significant history of heart disease, including certain types of heart failure, a heart attack within the past 6 months, serious irregular heart rhythms, or a history of prolonged QT interval on heart monitoring — with some exceptions that may be discussed with the medical team.
• People with a history of lung inflammation (ILD/pneumonitis) that needed steroid treatment, or who currently have or are suspected to have this condition based on imaging.
• People with certain serious or ongoing lung conditions, such as a blood clot in the lungs within the past 3 months, removal of an entire lung, severe asthma, severe COPD, restrictive lung disease, significant fluid around the lungs, or lung scarring following COVID-19.
• People with autoimmune, connective tissue, or inflammatory conditions (such as rheumatoid arthritis or sarcoidosis) where there is known or suspected involvement of the lungs at the time of screening.
• People who received a live, weakened vaccine within 30 days before the first dose of study treatment (note: mRNA vaccines and certain other types are not considered live vaccines under this criterion).
• People with an active serious infection currently requiring intravenous antibiotics, antiviral, or antifungal treatment.
• People with active HIV, active hepatitis B, or active hepatitis C — though people with a known history of HIV whose viral load has been undetectable for at least 6 months and who are on effective treatment, or people with certain managed hepatitis B or C situations, may be eligible (confirm with trial site).
• People with other medical or psychiatric conditions that, in the investigator's view, could interfere with the study results or prevent them from completing the study.
• People who have already received chemotherapy or HER2-targeted therapy for advanced or metastatic breast cancer.
• People who received a specific type of antibody-drug therapy (containing an exatecan derivative) after surgery, with less than 12 months having passed since the last dose.
• People who need to continue taking medications that are prohibited under the study protocol, or who have previously used those medications.
• People who are currently enrolled in, or have recently participated in, another study involving an experimental drug within 30 days or within 5 half-lives of that drug (whichever is longer), unless the medical team approves.
• People with a known allergy or sensitivity to the study drug (T-DXd), its ingredients, or similar antibody-based medicines.
• People who are pregnant (confirmed by a blood test) or who are currently breastfeeding.
• In France only: people who are under legal guardianship or detained.

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