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 are willing to voluntarily sign a consent form and agree to follow the study requirements
• People aged 18 to 75 years old
• People whose doctors expect them to live for at least 3 months
• People with a good general health and activity level (rated 0 or 1 on a standard performance scale used by doctors)
• People who have been confirmed by lab testing of tissue or cells to have triple-negative breast cancer that cannot be surgically removed, has come back, or has spread to other parts of the body
• People who have not previously received systemic (whole-body) treatment for advanced, recurrent, or metastatic triple-negative breast cancer
• People who are able to provide a stored or freshly collected tumour tissue sample from within the last 2 years
• People who have at least one measurable tumour lesion, as defined by a standard medical measurement guideline (RECIST v1.1)
• People who have not had a blood transfusion or received certain blood cell-boosting medications in the 14 days before the screening phase, and whose organ function meets the study's required levels
• People whose side effects from any previous cancer treatment have mostly resolved to a mild level or better
• Women who could become pregnant must have a negative pregnancy test within 7 days before starting treatment, must not be breastfeeding, and all enrolled participants must use effective barrier contraception throughout treatment and for 6 months after treatment ends

Who may not be able to join:

• People who have previously received a type of drug called an antibody-drug conjugate (ADC) that uses topoisomerase I inhibitor toxins (confirm with trial site)
• People who have had palliative radiotherapy within 2 weeks before the first study dose
• People who received checkpoint inhibitor drugs as part of earlier chemotherapy before or after surgery
• People who have used immune-modifying drugs within 14 days before the first study dose
• People who have had a serious heart or stroke-related condition in the 6 months before screening
• People with certain heart rhythm or electrical conduction problems, including prolonged QT interval, complete left bundle branch block, third-degree heart block, or frequent uncontrolled irregular heartbeat
• People with active autoimmune or inflammatory conditions
• People who have been taking long-term oral steroid medication before the first study dose
• People who have had another cancer that was active or required treatment within the 5 years before the first dose
• People with poorly controlled diabetes, serious diabetes-related complications, a blood sugar control marker (HbA1c) of 8% or above, high blood pressure that remains uncontrolled despite two medications, or a history of hypertensive crisis or hypertensive brain injury
• People with moderate or severe radiation-related lung inflammation, or with a current interstitial lung disease (a type of lung condition)
• People with other lung diseases that cause serious breathing difficulties
• People who had blood clot-related events requiring treatment intervention in the 6 months before screening
• People whose cancer has spread to the brain and is currently active
• People with large or symptomatic fluid build-up in body cavities that is not well controlled
• People with a known allergy to the types of antibody used in the study drug, or to any of its ingredients
• People who have previously had an organ transplant or a bone marrow/stem cell transplant from a donor
• People who test positive for HIV, or who have active tuberculosis, active hepatitis B, or active hepatitis C
• People who have had a serious infection, or signs of a lung infection or active lung inflammation, within 4 weeks before the first dose
• People who have participated in another clinical trial within 4 weeks before the first dose
• People with superior vena cava syndrome (a condition affecting a major vein near the heart) who cannot receive extra fluids (confirm with trial site)
• People with a history of substance abuse they are unable to stop, or a history of severe neurological or psychiatric illness
• People whose scans show the tumour has grown into or around major blood vessels in the chest
• People with a serious wound, ulcer, or broken bone that has not healed within 4 weeks before signing the consent form
• People who have had significant bleeding or a clear tendency to bleed within 4 weeks before signing the consent form
• People who have received, or are planned to receive, a live vaccine within 28 days before the first dose
• People whom the trial investigators consider unsuitable for participation for other reasons

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