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 who have been diagnosed with advanced solid tumors (such as breast cancer or undifferentiated liposarcoma), confirmed by lab testing, whose cancer has stopped responding to a type of treatment called a CDK4/6 inhibitor — either during advanced-stage treatment, or within 12 months of finishing it before or after surgery.
• People who have at least one tumor that can be measured on a scan, according to standard criteria called RECIST 1.1.
• People aged 18 or older, of any gender.
• People whose general physical wellbeing falls within a certain range on a standard scale called the ECOG performance scale (scores 0, 1, or 2 — meaning able to carry out at least some daily activities).
• People whose doctors expect them to live for at least 3 months.
• People whose recent blood test results (within one week before joining) show that white blood cell counts, red blood cell levels, and platelet counts are within acceptable ranges, without having needed a blood transfusion or blood-boosting medication in the 14 days before testing.
• People whose recent liver and kidney function test results (within one week before joining) are within acceptable ranges set by the study laboratory.
• People who are able to have children (male or female) and agree to use reliable contraception with their partner during the trial and for at least 3 to 6 months after the last dose of the study medication.
• Women who have not yet gone through menopause and can confirm a negative pregnancy test (blood or urine) before joining, and commit to using contraception during the study and for 6 months after it ends.

Who may not be able to join:

• People who have had major surgery on internal organs (not including needle biopsies) or a serious physical injury within 4 weeks before the first dose of the study drug.
• People who have previously been treated with radiation therapy and two or more different CDK4/6 inhibitors for advanced or metastatic disease.
• People who have not recovered sufficiently from side effects of previous cancer treatments — specifically, side effects that remain above a mild level (with some exceptions, such as hair loss or manageable immune-related reactions) — or who have moderate to severe nerve-related symptoms in their hands or feet from previous treatment.
• People who have active or uncontrolled cancer spread to the brain or the lining around the brain, or symptoms suggesting this.
• People who are pregnant (confirmed by a positive pregnancy test) or currently breastfeeding.
• People with an active infection requiring ongoing antibiotic or antiviral treatment that is not yet under control (minor urinary infections without symptoms may be excepted); people who test positive for HIV; people with active hepatitis B (unless well-controlled with antiviral treatment); or people who test positive for hepatitis C antibodies.
• People with a history of serious heart or blood vessel conditions — including significant heart rhythm problems, certain types of heart block, heart attack, heart failure, aortic tearing, or stroke within the past 6 months — or whose heart's electrical activity (measured on an ECG) shows a reading above a certain level, or whose blood pressure is not well controlled.
• People with psychiatric conditions or who may have difficulty following the study requirements.
• People who cannot use a medication called hydroxychloroquine because of existing disease affecting the blood vessels in the eyes.
• People whom the trial doctors consider unsuitable for the trial for any other medical reason.

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