AFT-38/HCC 17-132: PATINA Trial

STUDY BASICS

Have you been diagnosed with metastatic breast cancer that is hormone receptor-positive and HER2-positive (HR+/HER2+)? If so, you may be able to participate in a research study to help find out if adding a drug called palbociclib (IBRANCE®) to standard treatment can help prevent the cancer from growing or spreading.

STUDY PURPOSE

Metastatic breast cancer is breast cancer that has spread outside of the breast and lymph nodes to other parts of the body. There is currently no cure for metastatic breast cancer, but treatments may help keep it under control. The purpose of this study is to find out if adding an investigational medicine called palbociclib (also known by the brand name IBRANCE®) to standard treatments can help prevent the cancer from growing or spreading to other parts of the body. Palbociclib works by targeting and blocking proteins that help cancer cells grow.

COULD THIS STUDY BE RIGHT FOR YOU?

• Age 18 and up
• Diagnosed with metastatic breast cancer that is hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-positive (HER2+)

WHAT PARTICIPANTS CAN EXPECT

Participation involves:

• A screening phase to be sure you are eligible to participate in the study
• Completing an initial regimen of standard chemotherapy and anti-HER2 therapy (if you have already started standard therapy, you may still be eligible)
• If your cancer does not get worse during the initial regimen of standard therapy, study treatments will be started. Participants will be randomly assigned (like the flip of a coin) to receive standard therapy (endocrine therapy and anti-HER2 therapy) plus palbociclib OR standard therapy (endocrine therapy and anti-HER2 therapy) without palbociclib.
• During the course of the study, participants may have the following tests and assessments: physical exam, blood draws, pregnancy tests, electrocardiogram, MUGA scan, bone scan, PET/CT/MRI scan, and biopsy.