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:

• You are a woman aged 18 to 75 years old
• You have been diagnosed with invasive breast cancer confirmed by a tissue biopsy
• Your breast cancer tests positive for HER2 (at a level called IHC 3+, or IHC 2+ with a positive FISH test), and your cancer meets certain size or lymph node criteria — including some higher-risk features such as grade 3, hormone receptor negative status, or being under 35 years old (confirm with trial site for your specific situation)
• You have already had either a full mastectomy or breast-conserving surgery (lumpectomy), along with lymph node assessment, within the past 90 days
• Your hormone receptor status (ER/PR) has been tested and the results are known
• You are generally well enough to carry out light activity and care for yourself (confirm with trial site)
• Your blood counts, kidney function, and liver function all meet the required healthy levels based on blood tests (confirm with trial site)
• You are willing to participate, have signed a consent form, and are able to attend follow-up appointments

Who may not be able to join:

• Your breast cancer has come back or spread to other parts of the body
• You have taken part in another clinical trial within the past 4 weeks (or longer, depending on the treatment used)
• You have previously been treated with certain HER2-targeting drugs called tyrosine kinase inhibitors, such as lapatinib, neratinib, or pyrotinib
• You have been diagnosed with another type of cancer within the past 5 years, with the exception of certain skin cancers or cervical pre-cancer that have been fully treated and cured
• You are currently receiving anti-cancer treatment through another clinical trial
• You have difficulty swallowing, ongoing severe diarrhea, or a bowel blockage that could affect how you absorb medication
• You have had a major surgery unrelated to breast cancer within the past 4 weeks, or have not fully recovered from such a surgery
• You have a known allergy to any ingredients in the study drugs, or have HIV, active hepatitis B, hepatitis C, or have had an organ transplant
• You are currently pregnant or breastfeeding, or you are able to become pregnant but are unwilling to use effective contraception throughout the trial
• You have a heart condition, including irregular heartbeat requiring medication, a history of heart attack, heart failure, or other significant heart problems
• You have other serious health conditions that could affect your safety or the study results, such as uncontrolled high blood pressure, severe diabetes, or an active infection
• You have a history of neurological or mental health conditions such as epilepsy or dementia
• You are currently taking certain medications that interact with a liver enzyme called CYP3A4, or drugs known to affect heart rhythm (confirm with trial site for specific medications)
• The trial doctor has any other concern about your suitability to participate

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