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 aged 18 to 75 years who have been diagnosed with breast cancer, whether they have gone through menopause or not
• People whose breast cancer has been confirmed by a laboratory test to be hormone receptor-positive (meaning the cancer responds to hormones like oestrogen or progesterone) and HER2-negative (meaning the cancer does not have high levels of a certain protein called HER2)
• People whose cancer meets certain size and spread criteria: either a smaller tumour with specific high-risk features, a larger tumour that has not spread to lymph nodes, or any tumour size where lymph nodes are affected but the cancer has not spread to distant parts of the body
• People who are generally well enough to carry out daily activities, rated 0 or 1 on a standard medical scale called the ECOG performance scale
• People who are willing to take part in the study and sign a consent form agreeing to participate
• People who agree to have a specific blood test (called ctDNA testing) done during the study to look for traces of cancer DNA
• People whose blood counts, kidney, liver, and heart function all fall within acceptable ranges as determined by blood tests and a heart scan (confirm with trial site for specific values)
• Women who could become pregnant must have a negative pregnancy blood test within 7 days before joining the study, and must agree to use non-hormonal contraception from signing the consent form until 2 months after the last treatment

Who may not be able to join:

• People whose breast cancer has been confirmed as HER2-positive
• People diagnosed with inflammatory breast cancer (a type of breast cancer that causes redness and swelling)
• People whose breast cancer has already spread to distant parts of the body (Stage IV or metastatic disease)
• People who have cancer in both breasts
• People who have had breast cancer before, including a pre-invasive type called ductal carcinoma in situ
• People who have already received any treatment for their current breast cancer, including hormone therapy, chemotherapy, immunotherapy, radiation, or certain surgical procedures on the lymph nodes
• People who have been diagnosed with any other cancer in the past 5 years, except for certain fully cured skin cancers or cervical pre-cancer (confirm with trial site)
• People with a history of serious lung disease, such as a condition called interstitial pneumonia
• People with HIV, AIDS, active hepatitis B, hepatitis C, or a combination of hepatitis B and C infections
• People who have experienced serious heart-related events in the 6 months before joining, such as a heart attack, severe chest pain, significant heart failure, certain irregular heart rhythms, a stroke or mini-stroke, or a blood clot in the lungs
• People who have had a serious active infection requiring intravenous (drip) treatment in the 4 weeks before joining, or who have an unexplained high fever during the screening period
• People who have a known allergy to any of the study drugs or their ingredients
• People who are currently taking part in another clinical drug trial
• People who are pregnant or breastfeeding
• People who are unwilling to attend follow-up appointments
• People with other serious physical or mental health conditions, or significant abnormal test results, that the trial doctors consider would make participation unsafe or unsuitable

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