Phase 1 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 who have been diagnosed with breast cancer that has spread to other parts of the body, where the cancer is hormone receptor positive (HR+) and HER2 negative, confirmed by a laboratory test on a tissue sample.
• People whose cancer tests show that at least 10% of cancer cell nuclei are positive for estrogen and/or progesterone receptors.
• People whose cancer tests show HER2 negative status, based on specific laboratory scoring methods (confirm with trial site for exact testing details).
• People whose cancer has gotten worse while being treated with a specific type of targeted therapy called a CDK 4/6 inhibitor (specifically ribociclib or abemaciclib — not palbociclib) combined with a hormonal therapy (an aromatase inhibitor such as anastrozole, letrozole, or exemestane, or fulvestrant).
• People who were previously on palbociclib but switched to ribociclib or abemaciclib for side effect management (not disease progression), and were stable on the new medication for at least three months before joining.
• People whose cancer can be measured on scans according to standard criteria (called RECIST 1.1).
• Women who could become pregnant must agree to use effective contraception before, during, and for 3 weeks after the study, and must have a negative blood pregnancy test within 7 days before registering.
• Men and women who have not yet gone through menopause must be receiving ovarian suppression treatment with a specific type of hormone injection (LHRH agonist).
• People aged 18 or older at the time of signing consent.
• People with a life expectancy of at least 12 weeks.
• People who are generally well enough to care for themselves and carry out light activity (this is measured on a standard scale called ECOG, and a score of 0 or 1 is required).
• People whose blood tests show that the kidneys, liver, and bone marrow are working at an adequate level (confirm specific numbers with trial site).
• People who have had brain metastases that have already been treated, provided that follow-up brain scans taken at least 6 weeks after treatment show the cancer has not grown.
• People who have enough tissue or blood samples available to meet the laboratory requirements of the trial.
• People with a history of heart problems must have a heart function assessment rating of class 2B or better on a standard scale used by doctors (called the New York Heart Association Classification).
• People who are able to understand and willing to sign a written consent form.

Who may not be able to join:

• People who have received any treatment for their metastatic breast cancer other than hormonal therapy combined with a CDK 4/6 inhibitor (previous palliative radiation to specific areas or bone-strengthening medications are exceptions).
• People who have brain metastases or cancer spread to the lining of the brain or spinal cord that has not yet been treated, or that is currently getting worse.
• People currently using nitrate medications and PDE5 inhibitor medications at the same time (confirm with trial site for examples of these medications).
• People taking strong medications that significantly affect how the body processes certain drugs (called potent CYP3A4 inhibitors or inducers), unless those medications can be stopped at least two weeks before joining the trial.
• People with any other illness or condition that the treating doctor believes could affect their safety or their ability to follow the study requirements.
• People who are currently pregnant or breastfeeding.
• People who have had another invasive cancer diagnosis within the past 2 years, with the exception of certain non-melanoma skin cancers (squamous cell or basal cell carcinoma) treated locally.

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