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 to 75 years old
• People whose general health and ability to carry out daily activities meets a standard the trial uses to measure fitness for treatment (known as ECOG performance status 0–1; confirm with trial site if unsure what this means)
• People whose primary breast tumour is larger than 1 cm
• People diagnosed with invasive breast cancer confirmed by tissue testing, at a stage ranging from Stage I through to Stage III (specific stage combinations apply; the trial site can confirm whether a particular stage qualifies)
• People whose breast cancer tests show a high level of a protein called HER2 (either IHC 3+, or IHC 2+ confirmed by a further test called ISH)
• People whose blood counts are within acceptable ranges without recent transfusions or growth factor injections in the prior 14 days (specific levels apply; the trial site will assess this)
• People whose liver and kidney blood test results are within acceptable ranges (specific levels apply; the trial site will assess this)
• People whose heart pumping function, measured by an ultrasound of the heart, is 55% or above
• Women who could become pregnant must have a negative pregnancy test within 7 days before joining, and must agree to use effective contraception during the trial and for 8 weeks after the last dose
• People who are willing to give written consent and to follow the trial schedule and procedures

Who may not be able to join:

• People who have previously received any treatment for breast cancer, including chemotherapy, radiation, targeted therapy, or hormone therapy
• People currently receiving any other cancer treatment
• People with cancer affecting both breasts, a type called inflammatory breast cancer, or a type where the primary tumour location cannot be found (occult breast cancer)
• People whose breast cancer has not been confirmed by tissue testing
• People who have had another type of cancer in the past 5 years (an exception may apply for certain successfully treated cervical conditions; confirm with trial site)
• People with serious problems affecting the heart, liver, or kidneys
• People who have difficulty swallowing, persistent diarrhoea, or a bowel blockage that could affect taking or absorbing oral medication
• People who have taken part in another clinical drug trial within the 4 weeks before joining
• People with a known allergy to any component of the study drug, a history of immune system deficiency (including HIV, active hepatitis B or C), or a history of organ transplant
• People with a history of significant heart conditions, including irregular heart rhythm requiring medication, a previous heart attack, heart failure, or other heart conditions the trial doctor considers unsuitable
• Women who are pregnant or breastfeeding, or women who could become pregnant but test positive on a pregnancy test at the start or are unwilling to use contraception throughout the trial
• People with any other serious uncontrolled condition the trial doctor considers a risk to safety or likely to interfere with completing the trial, such as severely uncontrolled high blood pressure, uncontrolled diabetes, or an active infection
• People with a history of neurological or psychiatric conditions, such as epilepsy or dementia, or any other condition the trial doctor considers incompatible with participation

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