Phase 2 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:

• Women between 18 and 75 years of age
• People with a laboratory-confirmed breast cancer diagnosis showing the tumour is driven by estrogen (ER-positive, at least 10%) and does not overexpress a protein called HER2 (HER2-negative), as defined by specific testing standards
• People whose tumour shows a Ki-67 score of 20% or higher, measured from a core needle biopsy — this is a marker of how quickly the cancer cells are growing
• People newly diagnosed with breast cancer at an early to locally advanced stage (Stage I to IIIA) who have not yet received any treatment
• People who are generally well enough to carry out daily activities, based on a standard medical fitness scale (ECOG score of 0 or 1)
• People whose blood counts are within acceptable ranges, showing the bone marrow is working well enough (confirm with trial site for specific values)
• People whose liver and kidney function test results are within acceptable ranges (confirm with trial site for specific values)
• People whose heart is pumping at 50% efficiency or above, as measured by an ultrasound of the heart
• People with a normal heart rhythm measurement (QT interval of 480 milliseconds or less) on a heart tracing test
• People who are willing and able to have a tumour biopsy taken
• People who are able to provide written consent to participate

Who may not be able to join:

• People who have previously received any cancer treatment, including chemotherapy, radiation, targeted therapy, or hormone therapy
• People currently receiving other cancer treatments at the same time
• People with breast cancer affecting both breasts, a type called inflammatory breast cancer, or a type where the primary tumour cannot be found (occult breast cancer)
• People with Stage IV (advanced/spread) breast cancer
• People whose breast cancer has not been confirmed through laboratory tissue testing
• People who have had another cancer in the past 5 years, with the exception of certain pre-cancerous cervical conditions that have been fully treated
• People with serious problems affecting the heart, liver, or kidneys
• People who have difficulty swallowing, persistent diarrhoea, or a blockage in the intestines that may prevent them from taking oral medication
• People who have taken part in another interventional clinical trial within the 4 weeks before joining this study
• People with a known allergy to any of the study drugs, a history of immune system problems (including HIV, active hepatitis B or C, or other immune conditions), or a history of organ transplant
• People with a significant history of heart disease, including treated irregular heartbeats, heart attack, heart failure, or other heart conditions the investigator considers a concern
• People who are pregnant or breastfeeding, those with a positive pregnancy test at the start of the study, or those unwilling to use effective contraception throughout the study
• People with serious ongoing health conditions — such as uncontrolled high blood pressure, severe diabetes, or an active infection — that the investigator considers a risk to safety or participation
• People with a history of neurological or psychiatric conditions, including epilepsy or dementia
• People who, in the investigator's judgement, are unsuitable for any other reason

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