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:

• Women who are able and willing to give written consent to participate
• Women aged 18 or older
• Women who are postmenopausal, either confirmed by at least 12 months without a period (along with hormone blood test results in the postmenopausal range), or confirmed by surgical removal of both ovaries at least 14 days before the trial starts
• People with a breast tumour measuring at least 1.0 cm (confirmed by ultrasound), ranging up to certain larger tumour sizes
• People whose breast cancer has tested positive for estrogen receptors (ER+), meaning at least 10% of tumour cells show this marker on testing
• People whose breast cancer has tested negative for HER2 protein (HER2-)
• People with breast cancer in more than one area of the breast, provided at least one tumour is 1.0 cm or larger and all confirmed tumours meet the ER+ and HER2- criteria above
• People who have not previously received any treatment for their breast cancer (no chemotherapy, hormone therapy, surgery, or radiotherapy)
• People whose doctor considers hormone-based treatment to be appropriate for their cancer
• People whose tumour has a Ki67 score of 10% or higher (a marker of how quickly cancer cells are growing), confirmed by local and central laboratory testing
• People whose breast cancer is suitable for surgery as a primary treatment
• People who are generally well enough to carry out light activity and care for themselves (confirmed with trial site)
• People with adequate blood counts, kidney function, liver function, and clotting levels as measured by blood tests (specific values to be confirmed with trial site)
• People who are able to swallow oral (tablet/capsule) medications

Who may not be able to join:

• People with invasive breast cancer in both breasts at the same time
• People whose breast cancer has spread to distant parts of the body (spread to nearby underarm lymph nodes may still be permitted — confirm with trial site)
• People with inflammatory breast cancer
• Women who are not postmenopausal
• People who have previously received any systemic or local treatment for breast cancer, including aromatase inhibitors, tamoxifen, certain hormone-blocking drugs, or CDK4/6 inhibitor medicines
• People with active or significant heart problems, including: a resting heart rate below 50 beats per minute within the past 2 years, chest pain or coronary heart disease within the past 12 months, a history of moderate-to-severe heart failure or heart muscle disease, certain abnormal heart rhythm measurements on an ECG, certain abnormal ECG findings (such as specific electrical conduction problems), or a history of or risk factors for dangerous heart rhythm problems within the past 12 months (some exceptions may apply — confirm with trial site)
• People with a known significant history of liver disease, such as moderate-to-severe liver failure or active hepatitis
• People with a history of invasive breast cancer, certain non-invasive breast conditions, or any other cancer within the past 5 years
• People with a documented history of abnormal bleeding, clotting disorders, or blood clots
• People currently using reproductive hormone treatments such as the contraceptive pill, hormone replacement therapy, or certain hormone-based medicines
• People with an active serious bacterial infection requiring intravenous antibiotics, an active fungal infection, or certain detectable viral infections including HIV, active hepatitis B, or active hepatitis C
• People with serious or uncontrolled medical conditions that the investigator believes would make participation unsafe, such as certain lung conditions, severe breathing difficulties requiring oxygen, severe kidney impairment, a history of major stomach or bowel surgery, Crohn's disease, ulcerative colitis, or ongoing diarrhoea at a moderate or severe level
• People with a known allergy or sensitivity to any of the study drugs or their ingredients
• People with a history of not following prescribed medical treatment plans
• People who are unwilling to have blood and tissue samples taken as part of the trial
• People who are unable or unwilling to follow the trial procedures
• People who have had major surgery within 14 days before screening
• People who are pregnant or breastfeeding
• People who have taken part in another clinical trial within the past 30 days (or longer, depending on the previous treatment), or who are currently enrolled in another medical research study that may conflict with this trial
• People with a known history of HIV or AIDS

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