Using a Computer Model to Identify Treatment Options in Advanced Metastatic Breast Cancer (SYNTHESIS-Breast)

About the Study

Researchers want to know if a computer program can help choose FDA-approved drugs that will treat metastatic breast cancer more effectively. 

What the Study Involves

People will be pre-screened before being allowed in the study. A sample of tissue taken from the tumor will be tested for biomarkers and run through a program to find possible treatments. Tissue from a biopsy taken within the last 6 months may be acceptable. 

Participants will be assigned to 1 of 3 groups based on AI search results:

• Group 1: No drug option was recommended. Participants will continue with their standard treatment with their local doctors.
• Group 2: A drug already FDA-approved for the participant's breast cancer was recommended, but the participant has not yet received it. These results will be sent to the participant's local doctors. Participants may return to the NIH if their disease gets worse after using the suggested drugs.
• Group 3: A drug approved for other uses was recommended. Participants will be treated with the recommended drugs at the NIH; their care will be managed by an NIH doctor. They will continue to receive treatment as long as the drugs are helping them. They will have follow-up visits for 2 years after treatment ends. For people out of town, travel expenses and accommodations may be covered by NIH. 

Participants who are not treated at the NIH will be contacted for a check on their health every 3 months for 2 years.

People 18 years of age or older are eligible to participate if the following applies:

• A confirmed diagnosis of metastatic breast cancer. 
• Must have been treated with at least one (1) line of systemic therapy after diagnosis of metastatic cancer, that had to be discontinued due to the disease getting worse or due to treatment side effects. Participants must not have any other treatment options available that have been shown to improve overall survival. 
• People with stable brain metastasis with no symptoms may be eligible if their treatment was at least 4 months before beginning the study. 
• Must have measurable disease.
• Previous tumor samples must be available from a biopsy performed within the past 6 months. If no biopsy has been performed in the last 6 months, and none is scheduled, participants may be able to have a biopsy completed at NIH.  
• Able to take oral medications.
• People with an existing diagnosis of diabetes or high blood pressure, must have disease well-controlled.
• People with chronic infections must have the disease well controlled.
• People with current symptoms or a history of heart problems should have a clinical risk assessment of heart function.
• Able to understand and willing to sign a written informed consent document.

• Whose cancer is rapidly getting worse.
• People with symptoms related to spread to the brain.
• With active heart problems, such as congestive heart failure.
• On constant supplemental oxygen.
• On dialysis for kidney failure.
• With another uncontrolled illness.
• Participants who cannot undergo a new biopsy or who do not have stored tumor sample that can be used for the study.