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Protocol No. E2112

Principal Investigator Tevaarwerk, Amye

Phase III

Age Group Adult

Scope National

Sponsor Type Institutional; National

Title A Randomized Phase III Trial of Endocrine Therapy plus Entinostat/Placebo in Postmenopausal Patients with Hormone Receptor-Positive Advanced Breast Cancer

Objective The purpose of this study is to find out what effects, both good and bad, an experimental drug called entinostat has on you and your cancer, when given together with the standard hormonal drug treatment, exemestane. Exemestane is an aromatase inhibitor which is used in breast cancer patients to inhibit the growth of the breast cancer. In this study, you will take exemestane, and either entinostat or an inactive substance (placebo). Eninostat is investigational and has not been approved by the Food and Drug Administration (FDA) for use in this cancer. If you are male, you will also receive Goserelin, a luteinizing hormone releasing hormone (LHRH) agonist that is used to suppress the production of testosterone and estrogen.

Description You will be "randomized" into one of the study groups. Randomization means that you are put into a group by chance (like flipping a coin) by a computer program. Neither you nor your doctor can choose the group you will be in. You will have equal chance of being placed in either group. If you are in group A, you will take entinostat in addition to your exemestane. If you are in group B, you will take an inactive substance (called a "placebo") in addition to your exemestane. Click here for more info

Key Eligibility
  • Must be estrogen receptor( ER) and/or progesterone receptor (PR) positive confirmed adenocarcinoma of the breast.
  • Patients whose tumors have HER2 IHC 3+, ISH ≥ 2.0 are not eligible.
  • Patients must have measurable or non-measurable Stage III/locally advanced or metastatic carcinoma of the breast.
  • Postmenopausal women and all men are eligible for this trial.
  • Patients may have received one prior chemotherapy regimen for metastatic disease provided treatment was completed ≥ 3 weeks prior to randomization.
  • Prior radiotherapy must in general have been completed ≥2 weeks prior to randomization.

  • Applicable Disease Sites Breast

    Therapies Involved Cytotoxic Chemotherapy; Hormone Therapy

    Drugs Involved Entinostat (MS-275); aromasin (exemestane); exemestane; goserelin; placebo; zoladex (goserelin)

    Status Open

    Participating Institutions Aspirus UW Cancer Center (formerly Riverview Hospital); Aspirus Wausau Hospital, Aspirus Regional Cancer Center; Bellin Memorial Hospital/Cancer Team at Bellin Health; Dean Health System, Hematology and Oncology Clinic ; Johnson Creek, UW Cancer Center; Langlade Memorial Hospital, Aspirus Regional Cancer Ctr; Mercy Health Systems, Janesville ; Swedish American Hospital, Rockford ; UW Hospital and Clinics; UWCCC 1 South Park