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 aged 18 or older who are willing and able to sign a consent form and attend follow-up visits as required by the study.
• People with breast cancer that has been confirmed by laboratory testing to be HER2-positive, and where the cancer cannot be surgically removed or has spread to other parts of the body.
• People whose breast cancer has been tested and found to be either hormone receptor-positive or hormone receptor-negative, based on standard testing guidelines.
• People who have not previously received chemotherapy or HER2-targeted treatment for advanced or metastatic breast cancer (first-line hormone therapy for metastatic disease is allowed). People who received chemotherapy or HER2-targeted treatment before or after surgery may still be considered, as long as it has been more than 6 months since that treatment ended before the cancer was diagnosed as advanced or metastatic.
• People with a general health and activity level rated as 0 or 1 on a standard medical scale (meaning fully active or able to carry out light work).
• People whose cancer has been shown to have grown or spread since their last treatment.
• People expected to live for at least 12 weeks at the time of screening.
• People who have at least one area of cancer that can be measured on a scan and has not previously been treated with radiation, meeting specific size requirements on CT or MRI imaging.
• People whose heart is pumping at 50% or better efficiency, confirmed within 28 days before joining the trial.
• People whose blood tests show that their blood cell counts, liver function, kidney function, and other organ measurements meet specific levels set by the trial (confirm with trial site for exact values).
• Women who could become pregnant must have a negative blood pregnancy test at the screening visit.
• Women who could become pregnant, or men whose partners could become pregnant, must use effective contraception throughout the entire trial and for 6 months after treatment ends.

Who may not be able to join:

• People who have previously been treated with a type of drug called an antibody-drug conjugate (ADC) that contains a camptothecin-based component (a topoisomerase I inhibitor).
• People with serious or uncontrolled heart or blood vessel problems, including a heart attack or significant heart failure within the past 6 months, uncontrolled high blood pressure despite treatment, a stroke or blood clot in an artery within the past 6 months, a serious blood clot in a vein or lungs within the past 3 months, certain serious heart rhythm problems, or a heart electrical interval (QTcF) that is too long on an ECG recording.
• People with a personal or close family history of an inherited condition causing long QT syndrome, or unexplained sudden death in a close family member under the age of 40.
• People with lung inflammation (pneumonitis) that requires steroid treatment, or certain other significant lung conditions such as interstitial lung disease, pulmonary fibrosis, or severe radiation-related lung damage, or where these conditions cannot be ruled out on a scan at screening.
• People with other significant ongoing lung problems, including severe asthma, severe COPD, significant fluid around the lungs, lung scarring after COVID-19, or certain autoimmune conditions affecting the lungs, or people who have had a lung surgically removed.
• People who have received certain cancer treatments too recently before starting the study — including antibody-based treatments within 4 weeks, hormone or non-antibody immunotherapy within 3 weeks, certain radiation therapy within 2 to 4 weeks, oral chemotherapy or small molecule targeted drugs within 2 weeks or 5 half-lives (whichever is longer), or live vaccines within 4 weeks.
• People who have had major surgery or a serious injury within the past 4 weeks, or who have wounds that have not fully healed.
• People who have taken certain medications that strongly affect how the body processes drugs (strong CYP3A4 inhibitors or inducers) within the past 2 weeks or 5 half-lives (whichever is longer).
• People who have used immune-suppressing medications within 14 days before starting the study (with some exceptions for low-dose or inhaled steroids).
• People with brain or spinal cord metastases that are causing symptoms, or cancer that has spread to the fluid around the brain or spine. People with small, stable, symptom-free brain metastases that meet specific criteria may still be considered (confirm with trial site).
• People who still have significant side effects from previous cancer treatment that have not improved to a mild level or returned to their baseline, with some exceptions for stable, manageable long-term effects.
• People whose cancer is growing into or pressing on major structures such as large blood vessels, the heart, windpipe, or food pipe.
• People who have had a life-threatening bleed requiring a blood transfusion or procedure within the past 3 months.
• People with fluid build-up around the abdomen, lungs, or heart that is causing symptoms and needs active treatment.
• People with varicose veins in the food pipe or stomach that need urgent treatment, or who are considered at high risk of bleeding from these veins, unless a specific assessment has been done within 3 months.
• People with blockages, holes, or abnormal connections in the digestive tract that have not healed, or people with conditions such as Crohn's disease, ulcerative colitis, chronic diarrhoea, or a history of extensive bowel removal.
• People who have had a stent placed in the windpipe or digestive tract and have not returned to normal eating or bowel function.
• People with a blockage in the bile ducts that has not been treated and resolved to an acceptable level.
• People with serious liver conditions such as hepatic encephalopathy, hepatorenal syndrome, or advanced cirrhosis.
• People with serious malnutrition requiring nutrition delivered directly into a vein, unless this has not been used in the 4 weeks before starting the study.
• People with uncontrolled active infections, including those requiring antibiotic, antiviral, or antifungal treatment, or people with HIV, active hepatitis B or C meeting specific criteria, active or recently treated tuberculosis, or active or untreated syphilis.
• People with a history of immune system deficiency conditions, whether present from birth or developed later in life.
• People who have had an organ transplant, bone marrow transplant, or stem cell transplant (except corneal transplants).
• Women who are pregnant or breastfeeding, or people planning to become pregnant.
• People who have a known allergy or sensitivity to any of the study drugs or their ingredients, including camptothecin-based components or HER2-targeted antibodies.
• People who have had another type of cancer diagnosed within the past 3 years (with some exceptions for certain low-risk skin cancers, treated non-invasive cancers, or papillary thyroid cancer).
• People currently participating in another interventional clinical trial (observational studies or follow-up from a completed trial are generally permitted).
• People with substance misuse issues, or other medical, psychological, or social conditions that the trial doctors believe could interfere with safe participation or make results difficult to interpret.
• People with mental health, neurological, or psychological conditions, or social circumstances that would make it difficult to follow the trial requirements or safely participate.

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