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A Single Arm Phase II Study of Palbociclib in Combination With Tamoxifen as First Line Therapy for Metastatic Hormone Receptor Positive Breast Cancer: Big Ten Cancer Research Consortium (BTCRC-BRE15-016) (16-053)
Primary Objective The primary objective of the Phase II study is to estimate the activity of the combination of palbociclib and tamoxifen in first line therapy for women with HR(+)/HER2(-) advanced breast cancer who have not received prior systemic anti-cancer therapies for their advanced/metastatic disease, assessed by response rates (complete or partial response) (RR) based on RECIST 1.1 or MDA criteria (for patients with bone only disease). Secondary Objectives - Characterize safety and tolerability of palbociclib and tamoxifen in first line therapy for women with HR(+)/HER2(-) advanced breast cancer who have not received prior systemic anti-cancer therapies for their advanced/metastatic disease. - Evaluate progression-free survival (PFS) per local assessment and RECIST 1.1 or MDA criteria in subjects with HR(+)/HER2(-) advanced breast cancer who have not received prior systemic anti-cancer therapies for their advanced/metastatic disease treated with palbociclib in combination with tamoxifen. - Evaluate clinical benefit rate RR (complete, partial response, or stable disease, lasting 24 weeks or longer) based on RECIST 1.1 or MDA criteria in subjects with HR(+)/HER2(-) advanced breast cancer who have not received prior systemic anti-cancer therapies for their advanced/metastatic disease treated with palbociclib in combination with tamoxifen. - Measure overall survival (OS) at 2 years in subjects with HR(+)/HER2(-) advanced breast cancer who have not received prior systemic anti-cancer therapies for their advanced/metastatic disease treated with palbociclib in combination with tamoxifen.
The primary objective of the Phase II study is to estimate the activity of the combination of palbociclib and tamoxifen in first line therapy for women with HR(+)/HER2(-) advanced breast cancer who have not received prior systemic anti-cancer therapies for their advanced/metastatic disease, assessed by response rates (complete or partial response) (RR) based on RECIST 1.1 or MDA criteria (for patients with bone only disease).
Histologically and/or cytologically confirmed diagnosis of ER positive and/or PR positive (ER>1%, PR>1%), Her2 negative breast cancer
No prior systemic anti-cancer therapy for advanced HR+ positive disease
Metastatic disease evaluable on imaging studies.
Adequate blood, liver and kidney function
Confirmed diagnosis of HER2 positive disease
Known uncontrolled or symptomatic CNS metastases.
Prior (neo)adjuvant treatment with tamoxifen within the 12 months before study entry.
Prior history of blood clots, pulmonary embolism or deep vein thrombosis.