Phase 2 Breast 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 who have signed a written informed consent before any trial procedures begin (if someone is physically unable to sign, a trusted person of their choice may sign on their behalf)
• Adults aged 18 or older
• People with a confirmed diagnosis of locally advanced inoperable or metastatic breast cancer that has tested positive for HER2, based on specific laboratory testing guidelines
• People who have an adequate stored tumour tissue sample available for specialised genetic testing at a central laboratory
• People whose general health and ability to carry out daily activities meets a certain level, rated as 0 or 1 on a standard medical scale (confirm with trial site)
• People who have been on continuous anti-HER2 targeted therapy (such as Trastuzumab, Trastuzumab/Pertuzumab, Trastuzumab-Deruxtecan, or T-DM1) for at least 2 years for their advanced or metastatic HER2-positive breast cancer, with no more than one treatment break of up to 3 months, and whose most recent scan showed a complete or partial response
• People with cancer affecting only the bones who have shown a complete metabolic response on a specific type of scan (18-FDG PET scan)
• People whose primary tumour has been treated with surgery and/or radiation therapy and is currently under control
• People with hormone receptor-positive disease, whether or not they have been receiving hormone therapy (hormone therapy must be continued if already in use, and ovarian suppression treatment is also permitted)
• People whose heart, kidney, blood, and liver function meet the hospital guideline requirements for this trial
• Women who could become pregnant must have a negative pregnancy test within 28 days before joining the trial
• Women who are not post-menopausal and men who are fertile must agree to use an approved contraception method during the study (hormonal contraceptives such as pills, patches, implants, or injections are not permitted for people with hormone receptor-positive disease)
• People who are willing and able to follow the full trial schedule, including visits, treatment, and follow-up
• People who are enrolled in a Social Security system or equivalent

Who may not be able to join:

• People whose breast cancer has shown any signs of progression in the past 2 years or at the time of joining the trial
• People currently using any cancer treatments other than trastuzumab, pertuzumab, Trastuzumab-Deruxtecan, or T-DM1, with or without hormone therapy
• People who have a history of cancer spreading to the membranes around the brain, or who have brain metastases that are untreated, causing symptoms, or requiring steroids or anti-seizure medication to manage (people with fully treated brain metastases that are no longer causing symptoms, no longer requiring steroids or anti-seizure medication, and have not progressed in the past 24 months may still be considered; however, people with brain metastases only, or who were treated with whole-brain radiotherapy, will not be eligible)
• People with serious ongoing conditions affecting the heart, liver, kidneys, or blood system that the treating doctor considers incompatible with trial participation
• People with a history of breast cancer in either breast, unless both cancers were confirmed to be HER2-positive (a prior diagnosis of DCIS is an exception)
• People with a history of other cancers, unless it was a skin cancer of a specific type or cervical carcinoma in situ, or unless the person has been free of the disease and its treatment for at least 3 years
• People who have had major surgery within 2 weeks before joining the trial
• People who are pregnant or currently breastfeeding
• People who are unable or unwilling to attend the required medical follow-up due to geographic, family, social, or psychological reasons
• People currently taking part in another clinical study whose procedures overlap with this one (within 28 days before joining and for the duration of the study)
• People who are under legal guardianship, protective custody, or are deprived of their liberty

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