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 aged 18 or older. Those who are pre-menopausal or peri-menopausal must have a negative pregnancy test and must agree to use effective contraception throughout treatment.
• People who have been confirmed through laboratory testing to have invasive breast cancer at Stage II or III, where the cancer tests positive for HER2 (either by a score of 3+ on a protein test, or a score of 2+ with a gene amplification test confirming HER2 positivity).
• People whose cancer includes at least one tumour that can be measured using standard imaging criteria.
• People who have not previously received chemotherapy, immunotherapy, hormone therapy, major surgery, or radiotherapy for their breast cancer.
• People whose general physical functioning is rated at a high level (able to carry out normal daily activities with little or no limitation, as assessed by a doctor using a standard scale).
• People who are able to understand and sign a written consent form.
• People whose blood and organ function results meet minimum thresholds — including blood cell counts, liver function, kidney function, and related measures — as confirmed by laboratory tests.
• People whose heart health meets specific requirements, including no signs of reduced blood flow to the heart on an ECG, normal heart pumping function of at least 55% on an echocardiogram, and normal heart-related blood markers.
• People who have had all required baseline tests and scans completed before starting treatment.
• People who have no difficulty swallowing.
• People whose complete medical records are available for the study.

Who may not be able to join:

• People with male breast cancer or a type called inflammatory breast cancer.
• People whose breast cancer has spread to other parts of the body (Stage IV).
• People who currently have, or have been diagnosed with, another cancer within the past 5 years — with the exception of certain treated skin cancers or early-stage cervical changes.
• People who are currently receiving other cancer treatments or taking part in another clinical trial.
• People with serious non-cancer health conditions that could affect their ability to safely participate in the trial.
• People who have had major surgery within 4 weeks before the trial starts, or who are expected to need major surgery during the trial period.
• People who have received radiotherapy, chemotherapy, targeted therapy, hormone therapy, or major breast surgery within 4 weeks before the trial, or who have previously been treated with certain HER2-targeted medications (including monoclonal antibodies, antibody-drug conjugates, or a class of drugs called tyrosine kinase inhibitors).
• People who have had a significant allergic reaction to, or medical reason to avoid, any of the drugs used in this trial.
• People with poorly controlled heart conditions — such as moderate-to-severe heart failure, unstable chest pain, a heart attack within the past year, or certain abnormal heart rhythms requiring treatment.
• People with dementia, an intellectual disability, or a psychiatric condition that affects their ability to understand and agree to the consent process.

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