Using a Computer Model to Identify Treatment Options in Advanced Metastatic Breast Cancer (SYNTHESIS-Breast)
Treatment
Treatment study for people with metastatic breast cancer
Clinicaltrials.gov identifier:NCT07067138
Study Contact Information:
Primary Contact:
Name: Ann C McCoy, R.N.
Phone Number: (240) 760-6021
Email: [email protected]
Secondary Contact
Name: Stanley Lipkowitz, M.D.
Phone Number: (240) 760-6129
Email: [email protected]
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.
This Study is Open To:
This Study is Open To:
People 18 years of age or older are eligible to participate if the following applies:
- A confirmed diagnosis of breast cancer.
- Must have been treated with at least one (1) line of after diagnosis of disease, that had to be discontinued due to progressive disease or adverse events. Participants must not be able to transition to another approved shown to improve overall survival.
- People with stable brain 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 .
- 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:
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.
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 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 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 .
Participants who are not treated at the will be contacted for a check on their health every 3 months for 2 years.
Study Contact Information:
Primary Contact:
Name: Ann C McCoy, R.N.
Phone Number: (240) 760-6021
Email: [email protected]
Secondary Contact
Name: Stanley Lipkowitz, M.D.
Phone Number: (240) 760-6129
Email: [email protected]
Locations:
Maryland
City: Bethesda RECRUITING
Facility: National Institutes of Health Clinical Center
Contact Info:
[email protected]
888-624-1937
Treatment
Treatment study for people with metastatic breast cancer
Clinicaltrials.gov identifier:NCT07067138
Study Contact Information:
Primary Contact:
Name: Ann C McCoy, R.N.
Phone Number: (240) 760-6021
Email: [email protected]
Secondary Contact
Name: Stanley Lipkowitz, M.D.
Phone Number: (240) 760-6129
Email: [email protected]