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All TopicsForum: Stage IV and Metastatic Breast Cancer ONLY → Topic: Clinical trial, endocrine tx plus entinostat or placebo, HR+

Topic: Clinical trial, endocrine tx plus entinostat or placebo, HR+

Forum: Stage IV and Metastatic Breast Cancer ONLY —

A place for those managing the ups & downs of a Stage IV/metastatic breast cancer diagnosis. Please respect that this forum is for Stage IV members only. There is a separate forum For Family and Caregivers of People with a STAGE IV Diagnosis.

Posted on: Jan 10, 2018 11:28AM - edited Jan 10, 2018 11:29AM by Moderators

Moderators wrote:

Announcement for those with advanced breast cancer (metastatic breast cancer)

You may qualify for a clinical trial for a potential new treatment.

What is it?

  • A randomized phase III trial of endocrine therapy plus entinostat or placebo in patients with hormone receptor-positive advanced breast cancer.

Who can participate?

  • Trial is open to pre-, and post menopausal women and all men with hormone receptor-positive breast cancer that cannot be removed by surgery (locally advanced) or has spread (metastasized) to another part of the body.
  • Patients will not be eligible if they are HER2-positive.

Learn more about who qualifies and find trial locations by visiting www.BreastCancerStudyE2112.com

Note:

More details re. ELIGIBILITY OF STUDY E2112
  • It is open to pre-, peri-, and postmenopausal women and all men with:
    1. hormone receptor– positive and/or progesterone receptor–positive breast cancer
    2. that cannot be removed by surgery (locally advanced) or has spread (metastasized) to another part of the body.
  • Patients will not be eligible if they are HER2 (human epidermal growth factor receptor-2)-positive.
  • Individuals who participate must have recovered from side effects of past therapies.
  • Hormone receptor-positive cancers may be more likely to respond to hormone therapies, such as exemestane.
  • Patients must have completed prior endocrine therapy at least two weeks before being assigned a study group; an exception is

    exemestane, which is allowed in patients with metastatic disease if they started exemestane within four weeks of being assigned to a study group.
  • Patients who received everolimus, prior palbociclib, or other cyclin-dependent kinase (CDK) inhibitor (

    ribociclib, abemaciclib) and prior fulvestrant use are allowed and may participate as long as the drug was completed two weeks before being assigned a study group.
  • Patients may not participate if they have been treated with entinostat, valproic acid (Depakote®, Epilim®, Valparin, Vilapro, Stavzor®), or vorinostat (Zolinza®).

See more detailed inclusion and exclusion criteria at clinicaltrials.gov

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