Stage IV Breast Cancer Clinical Trial
Official title:
A Phase II Single Arm Study of Palbociclib in Patients With Metastatic HER2-positive Breast Cancer With Brain Metastasis
The purpose of this study is to evaluate if the study drug palbociclib has anti-tumor activity against the breast cancer that has spread to the brain and also to determine the overall radiographic response rate in the CNS. Palbociclib is an anti-cancer medication that has been shown to stop cancer cells from growing. It has been approved in hormone positive breast cancer, along with other hormone therapies and has been found to be effective. The preclinical studies suggest that the drug may also have activity in other types of breast cancer, such as HER2 positive breast cancer. The purpose of this study is to see if the study drug is effective in patients with brain metastasis, who have HER2-positive breast cancer.
PRIMARY OBJECTIVES:
I. To determine the radiographic response rate in the central nervous system (CNS) in
patients with HER2-positive breast cancer who have brain metastasis treated with palbociclib.
SECONDARY OBJECTIVES:
I. To determine the progression-free survival (PFS) and overall survival (OS) in patients
with HER2-positive breast cancer who have brain metastasis treated with palbociclib.
II. To determine time to CNS progression in patients with HER2-positive breast cancer who
have brain metastasis treated with palbociclib.
III. To determine systemic overall response rate (ORR) in patients with HER2-positive breast
cancer who have brain metastasis treated with palbociclib.
IV. To determine the safety and tolerability of palbociclib in patients with and
HER2-positive breast cancer.
TERTIARY OBJECTIVES:
I. To evaluate circulating tumor deoxyribonucleic acid (DNA) at baseline, 2 month and 4
months; particularly to assess cyclin D1 aberrations, and if this is predictive of responses.
II. To evaluate genomic landscape of available CNS and non-CNS tumors, and describe any
discordance.
III. To evaluate cognitive function and quality of life at baseline, 2 and 4 months in
patients receiving palbociclib.
OUTLINE:
Patients receive palbociclib orally (PO) daily on days 1-21. Courses repeat every 28 days in
the absence of disease progression or unacceptable toxicity. Patients with HER2 positive
breast cancer may also receive trastuzumab intravenously (IV) as standard of care
concurrently with palbociclib.
After completion of study treatment, patients are followed up at 3, 6, 9, and 12 months, and
then every 6 months for up to 3 years.
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