This study is currently not recruiting participants.

E2112; A Randomized Phase III Trial of Endocrine Therapy Plus Entinostat/Placebo in Postmenopausal Patients With Hormone Receptor-Positive Advanced Breast Cancer

Investigating the Effectiveness of an Investigational Medication with Endocrine Therapy in Hormone Receptor-Positive Breast Cancer

Not Recruiting
18 years - 100 years
All
Phase N/A

Brief description of study.

This trial studies exemestane and entinostat to see how well they work compared to exemestane alone in treating postmenopausal patients with hormone receptor-positive breast cancer that has spread to nearby tissue or lymph nodes or another place in the body.

Detailed description of study

The purpose of this study is to evaluate whether the addition of entinostat to endocrine therapy (exemestane) improves progression-free survival (PFS) and/or overall survival (OS) in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer who have previously progressed on a non-steroidal aromatase inhibitor (Al).

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Breast Cancer
  • Age: 18 years - 100 years
  • Gender: All

This study investigates how well an investigational medication works with endocrine therapy compared to endocrine therapy alone in treating postmenopausal patients with breast cancer. The breast cancer in this study is hormone receptor-positive, meaning that the cancer cells grow in response to hormones, and it has spread to nearby tissues, lymph nodes, or other parts of the body.

Participants in this study will be assigned to different study arms. One group will receive the investigational medication along with endocrine therapy, while another group will receive only the endocrine therapy. The study will measure how long patients live without the cancer getting worse and overall survival rates.

  • Who can participate: Postmenopausal patients with hormone receptor-positive, HER2-negative breast cancer that is locally advanced or metastatic can participate. Participants should have previously progressed on a non-steroidal aromatase inhibitor.
  • Study details: Participants will receive either the investigational medication with endocrine therapy or endocrine therapy alone.
Updated on 19 Feb 2024. Study ID: 1403644196

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