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:

There are three groups (cohorts) in this trial. You may qualify for one of them:

Group 1 (starting first-line treatment):

• You have been diagnosed with breast cancer (men or women, any menopausal status), are at least 18 years old, and your cancer is hormone receptor-positive (HR+) and HER2-negative
• Your cancer has spread locally (cannot be removed by surgery) and/or to other parts of the body
• Your doctor considers you a suitable candidate to start a specific type of treatment combining hormone therapy with a CDK4/6 inhibitor (a targeted cancer drug) for the first time for your advanced/metastatic disease
• You may have had one previous course of chemotherapy for your advanced cancer, but you must not have had hormone therapy for your advanced/metastatic disease before
• You may have previously received chemotherapy or hormone therapy (with or without ovarian suppression) as part of earlier treatment before the cancer spread
• You may have previously received a CDK4/6 inhibitor as part of earlier treatment, as long as your doctor still considers you suitable for this type of drug now
• You are able to have a blood test called a liquid biopsy before starting treatment
• You are willing and able to read and sign a consent form

Group 2 (cancer has progressed after CDK4/6 inhibitor treatment):

• You have breast cancer (men or women, any menopausal status), are at least 18 years old, and your cancer is HR+ and HER2-negative
• Your advanced or metastatic cancer has gotten worse while being treated with a CDK4/6 inhibitor combined with hormone therapy (first or second line of treatment)
• All other Group 1 criteria that do not conflict with your situation also apply

Group 3 (currently on first-line treatment and responding well):

• You have breast cancer (men or women, any menopausal status), are at least 18 years old, and your cancer is HR+ and HER2-negative
• Your cancer has spread locally (cannot be removed by surgery) and/or to other parts of the body
• You have been on your first hormone therapy treatment combining an aromatase inhibitor with a CDK4/6 inhibitor (with or without ovarian suppression) for at least 6 months
• There is no sign that your cancer is currently getting worse based on scans or physical examination
• You are able to have a liquid biopsy blood test and are willing to sign a consent form

Who may not be able to join:

• Your breast cancer is not HR+ and HER2-negative
• Your advanced or metastatic breast cancer has not been confirmed by scans or tissue testing
• Your doctor does not consider you suitable for further cancer treatment after your diagnosis of advanced or metastatic disease
• You have already begun a CDK4/6 inhibitor combined with hormone therapy as your first treatment for metastatic disease (this applies to Group 1 only)
• You have already started a new treatment after your cancer got worse on a CDK4/6 inhibitor combined with hormone therapy (this applies to Group 2 only)
• There is any sign — on scans or physically — that your cancer may be getting worse at the time of your first liquid biopsy blood test (this applies to Group 3 only)
• You are not able to have a liquid biopsy blood test
• You are not able to understand or sign a consent form

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