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 at the time of signing consent forms
• Women who are postmenopausal — this includes those who have had both ovaries removed, are aged 60 or older, or are under 60 and have not had a period for 12 or more months (under specific conditions), or have hormone levels in the postmenopausal range
• People with a general health/activity level rated 0–2 on a standard medical scale, assessed within 28 days before joining (confirm with trial site)
• People diagnosed with early-to-mid stage (Stage I–III) invasive breast cancer with a tumour larger than 10mm
• People whose breast cancer tests positive for the HER2 protein (by current standard testing guidelines)
• People whose breast cancer tests positive for oestrogen receptors (at least 10% positive); progesterone receptor status does not matter
• People with breast cancer that can be surgically removed, where pre-surgery treatment is considered appropriate
• People who have stored tumour tissue from their original diagnostic biopsy available to send to the study site by Week 4
• People willing to have a repeat breast biopsy 3 weeks after starting treatment
• People whose treating doctor considers them suitable for either letrozole or anastrozole (hormone-blocking medications)
• People with a heart pumping function of 50% or higher, confirmed by a heart scan within 4 weeks before starting the study treatment
• People with adequate blood counts, kidney function, and liver function, confirmed by blood tests within 28 days before joining (confirm specific values with trial site)
• People living with HIV who are on effective antiviral treatment with an undetectable viral load within the past 6 months
• People with a history of hepatitis B who are on suppressive treatment with an undetectable viral load, or people with a history of hepatitis C who have completed treatment and been cured, or whose viral load is currently undetectable while on treatment
• People able to understand and follow all study procedures for the full duration of the trial, as assessed by the enrolling doctor

Who may not be able to join:

• People with locally advanced (Stage IIIC or higher) or inflammatory breast cancer
• People with signs that the cancer has spread to other parts of the body (metastatic disease)
• People with a current or past diagnosis of another cancer that could interfere with the trial's safety or results — exceptions may include certain skin cancers, some early-stage cancers, or cancers where the person has been cancer-free for at least five years (confirm with trial site)
• People currently dealing with an active infection that requires treatment with medication
• People who need to take certain medications known to interact with the study drugs (specifically moderate or strong CYP3A4 inhibitors or inducers — confirm with trial site)
• People who have taken part in another clinical drug trial within 14 days before joining, or within a timeframe based on that drug's duration in the body (whichever is longer)
• People who have had major surgery within 14 days before joining, or who have not yet fully recovered from major surgery (a tumour biopsy does not count as major surgery)
• People with significant stomach or bowel problems that could affect how the study medications are absorbed, or that would make swallowing capsules or tablets difficult
• People with a known history of certain blood or bone marrow disorders (myelodysplastic syndrome or acute myeloid leukaemia)
• People who have had a hole or tear in the gastrointestinal tract, an abdominal abscess, or an abdominal fistula within 28 days before joining
• People who have had a stroke or mini-stroke within the past 12 months
• People who have had a serious heart event — such as a heart attack, unstable chest pain, heart bypass surgery, or a stent procedure — or inflamed lining around the heart, within the past 6 months
• People with significant heart failure symptoms (rated Class III–IV on a standard scale) or a confirmed weak heart with pumping function below 50%
• People with serious heart rhythm problems, or certain types of abnormal electrical conduction in the heart, unless a pacemaker is already in place (confirm with trial site)
• People with a personal or family history of a heart condition called Long QT syndrome, or a family history of unexplained sudden death
• People with any other serious or uncontrolled medical condition that the treating doctor believes would make participation unsafe or impractical

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