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

About the Study

Some types of breast cancers are aggressive and difficult to treat. Researchers want to know if an artificial intelligence computer program called ENLIGHT, can help choose approved drugs that will treat these cancers more effectively. 

What the Study Involves

People will be screened before being allowed in the study. A sample of tissue taken from the tumor will be tested using ENLIGHT as well as another method. Tissue from a biopsy taken within the last 6 months may be acceptable. 

Participants will be assigned to 1 of 3 groups based on ENLIGHT 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 approved for the participant's disease 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.

This Study is Open To:

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 disease, that had to be discontinued due to progressive disease or adverse events. Participants must not be able to transition to another approved systemic therapy 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.

This Study is Not Open To:

• People experiencing rapid disease progression.
• People with symptoms related to tumors in the brain.
• People with active heart problems, such as congestive heart failure.
• People who receive constant supplemental oxygen.
• People on dialysis for kidney failure.
• Uncontrolled secondary illness.
• Participants who are unable to provide tumor tissue specimens of sufficient quality for use in this study.