Dose-finding Study of Capecitabine and Entinostat in Metastatic Breast Cancer

The study had two phases, a safety dose finding lead-in and second part efficacy study in the population of breast cancer patients with residual disease after neoadjuvant chemotherapy. The dose finding lead-in was required by regulatory authorities due to the absence of published safety data on the combination of capecitabine and entinostat. Details regarding the modeling approach and design considerations for both phases of the study have been provided in a prior report [19 (link)]. Due to drug supply limitations, the study closed after the first phase. For the first phase safety lead-in, metastatic breast cancer patients were enrolled. The patient population included female patients age 18 years and older, ECOG performance status of 0-2, with histologically confirmed diagnosis of metastatic, ER/PR-positive or negative, and HER2-negative breast cancer.

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Millard T., Brenin C., Humphrey C., Dhakal A., Falkson C., Petroni G., Wages N.A, & Dillon P. (2024). A Pilot Study of the Combination of Entinostat with Capecitabine in Advanced Breast Cancer. International Journal of Breast Cancer, 2024, 5515966.

Publication 2024

Corresponding Organization : University of Virginia

Other organizations : University of Rochester Medical Center, Virginia Commonwealth University

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Variable analysis

independent variables

Dose of capecitabine and entinostat

dependent variables

Safety and efficacy of the combination of capecitabine and entinostat in breast cancer patients with residual disease after neoadjuvant chemotherapy

control variables

Female patients age 18 years and older
ECOG performance status of 0-2
Histologically confirmed diagnosis of metastatic, ER/PR-positive or negative, and HER2-negative breast cancer

controls

Positive control: Not explicitly mentioned
Negative control: Not explicitly mentioned

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