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 have previously been treated with a drug called T-DXd and whose cancer got worse while on it, or within 2 months of stopping it for any reason (this does not need to have been the most recent treatment received)
• People with HER2-positive breast cancer who have previously been treated with trastuzumab and taxanes (prior treatment with T-DM1 and pertuzumab is also permitted)
• People with HER2-low breast cancer who have previously been treated with taxanes; if the tumour is also hormone receptor-positive, prior treatment with hormone therapy and CDK4/6 inhibitors is required (prior sacituzumab govitecan is also permitted)
• People who have a specific inherited gene change in BRCA1 or BRCA2 and HER2-positive or HER2-low breast cancer must have previously received a PARP inhibitor drug (olaparib or talazoparib)
• People aged 18 or older at the time of signing the consent form
• People who have a confirmed diagnosis of breast cancer that has spread or cannot be surgically removed
• People who are in generally good physical condition, able to carry out daily activities with minimal limitations (confirm with trial site regarding the specific fitness score required)
• People whose tumour tests show HER2-positive or HER2-low status (at any point before receiving T-DXd), with any hormone receptor status
• People who have at least one area of cancer that can be measured on a scan (separate from the biopsy site); people with cancer only in the bones must have at least one bone lesion with a measurable soft tissue component visible on CT or MRI
• People who have a tumour site that can be safely biopsied, and who agree to have biopsies taken before, during, and at the end of treatment
• People whose blood test results show adequate bone marrow, liver, and kidney function within 14 days before starting treatment
• Women who could become pregnant must have a negative pregnancy test shortly before starting treatment, and must agree to use a highly effective form of contraception — such as an intrauterine device (IUD), both tubes being blocked, a vasectomised partner, or complete abstinence from sex — during treatment and for at least 8 months after the last dose
• Women who could become pregnant must agree not to donate or collect eggs from the time of screening until at least 8 months after the last dose
• Male participants must agree to use effective contraception or avoid sex during treatment and for at least 5 months after the last dose, and must agree not to freeze or donate sperm from screening until at least 5 months after the last dose
• People who are able to understand and sign the consent form, and who are willing and able to attend all required study visits and procedures
• People who are covered by a social security or health insurance system (as required in the country where the trial is taking place)

Who may not be able to join:

• People whose breast cancer could potentially be removed by surgery or treated with radiation therapy with the aim of curing it
• People who have a history of, currently have, or are suspected to have a lung condition called interstitial lung disease (including pulmonary fibrosis or radiation-related lung inflammation)
• People with serious lung problems resulting from other lung conditions, such as pulmonary embolism, severe asthma, severe COPD, fluid around the lungs, or certain autoimmune diseases affecting the lungs; or people who have had a lung surgically removed
• People currently taking high-dose steroid tablets (more than 10 mg prednisone per day or equivalent) or other medicines that suppress the immune system (inhaled, topical, or local steroid injections may be acceptable — confirm with trial site)
• People who have cancer that has spread to the lining of the brain or spinal cord (leptomeningeal disease)
• People with significant disease affecting the corneas of their eyes
• People with severe or uncontrolled serious illness, including active infections, uncontrolled bleeding conditions, or significant psychiatric illness
• People with active or symptomatic brain metastases requiring steroids or anti-seizure medication (people with treated, stable, and symptom-free brain metastases may be eligible — confirm with trial site)
• People who have not waited long enough after their most recent treatment before joining — specific waiting periods apply depending on the type of treatment previously received (confirm with trial site)
• People who have previously been treated with an anti-HER3 antibody drug
• People who still have significant side effects from previous cancer treatments that have not resolved, with some exceptions for certain long-term low-level effects such as nerve damage, fatigue, or stable hormone-related conditions from immunotherapy (confirm with trial site)
• People with a known allergy to the study drug (HER3-DXd) or to T-DXd
• People with a history of severe allergic reactions to other monoclonal antibody drugs or PARP inhibitor drugs
• People who have had another cancer within the past 3 years, other than certain skin cancers or cancers treated with curative intent
• People with significant heart or cardiovascular problems, including abnormal heart rhythm, recent heart attack (within 6 months), poor heart pumping function, high blood pressure, or other serious cardiac conditions (confirm with trial site for the full list of specific heart-related criteria)
• People with an active hepatitis B or hepatitis C infection (people with past or resolved hepatitis B or C may be eligible depending on specific blood test results — confirm with trial site)
• Women who are pregnant, breastfeeding, or planning to become pregnant during the study
• People with HIV that is not well controlled (people with well-controlled HIV meeting specific criteria may be eligible for part of the study — confirm with trial site)
• People with any other serious ongoing illness, medical history, or abnormal test result that the trial doctor believes could affect safety or the reliability of results
• People who are under legal guardianship, deprived of their liberty, or unable to give their own consent
• People who have participated in another clinical trial testing an experimental drug within the last 4 weeks
• For the part of the trial involving olaparib: people with a known allergy to olaparib's ingredients, or who have not completed the required waiting period after taking certain other medications that interact with olaparib (confirm with trial site)

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