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 who are willing and able to sign and date the trial's consent form.
• People who agree to provide a tissue sample (either a new biopsy or one taken previously) from their cancer.
• People who have been diagnosed with breast cancer that cannot be surgically removed and/or has spread to other parts of the body.
• People whose breast cancer is either hormone receptor-positive or hormone receptor-negative (both types may be eligible).
• People whose breast cancer has a specific HER2 status — either "HER2-low" (IHC 1+ or IHC 2+ with a negative ISH test) or "HER2 zero" (IHC 0), confirmed through tissue testing using standard guidelines.
• People whose breast cancer has never previously tested as HER2-positive on any prior pathology test.
• People who have never received HER2-targeted treatment for metastatic breast cancer.
• People who have received at least one, but no more than two, prior treatment regimens for their metastatic breast cancer.
• People with hormone receptor-positive, HER2-low metastatic breast cancer who meet at least one of these additional conditions: their cancer returned within 2 years of starting a hormone-based therapy after surgery; or their cancer progressed on a CDK4/6 inhibitor-based treatment within 12 months of finishing that treatment after surgery; or their cancer progressed within the first 12 months of receiving a CDK4/6 inhibitor as their first treatment for metastatic disease.
• People who have at least one area of cancer that can be measured on a CT or MRI scan.
• People with small brain tumours (under 2 cm) that are untreated, not causing symptoms, and not requiring urgent medical attention may be eligible (confirm with trial site).
• People with a good general level of physical functioning, rated 0 or 1 on a standard medical scale (meaning fully active or able to carry out light activity).
• People with a life expectancy of at least 12 weeks at the time of screening.
• People whose heart is pumping at 50% or above efficiency, confirmed within 28 days before joining the trial.
• People with adequate organ and bone marrow function, confirmed within 28 days before joining.
• People who have waited a sufficient time after their last treatment before enrolling (confirm with trial site for specific timeframes).
• People of childbearing or reproductive potential who agree to use a highly effective form of contraception during the trial.

Who may not be able to join:

• People who have previously been treated with a type of cancer drug called an antibody-drug conjugate (ADC).
• People with uncontrolled or significant heart or blood vessel disease.
• People with a heart rhythm abnormality known as prolonged QT interval.
• People who have had a history of lung inflammation (interstitial lung disease or pneumonitis) that needed steroid treatment, currently have this condition, or where this condition cannot be ruled out by scans at screening.
• People with spinal cord compression or active cancer spread to the brain that is causing symptoms or requires treatment.
• People who have had more than one type of cancer in the past 3 years, with some exceptions (such as certain treated skin cancers, cancers treated with curative intent, or cancer in the other breast).
• People with a history of severe allergic reactions to the ingredients in the study drug.
• People with a history of severe allergic reactions to other monoclonal antibody medicines.
• People with an active, uncontrolled infection that requires intravenous antibiotics, antiviral, or antifungal medicines.
• People with an active primary immune system deficiency, uncontrolled HIV infection, or active hepatitis B or C infection.
• People who have received a live or weakened (attenuated) vaccine within 30 days before starting the study drug (note: mRNA vaccines and certain other types are not included in this restriction — confirm with trial site).
• People who still have unresolved side effects from previous cancer treatments (other than hair loss) that have not returned to mild or baseline levels.
• People who are pregnant, breastfeeding, or planning to become pregnant.
• People with certain significant ongoing lung conditions (confirm with trial site for specifics).
• People with autoimmune, connective tissue, or inflammatory disorders.
• People who have had a complete surgical removal of one entire lung.

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