Active — Not RecruitingPhase 3

Exemestane With or Without Entinostat in Treating Patients With Recurrent Hormone Receptor-Positive Breast Cancer That is Locally Advanced or Metastatic

United States, South Africa608 participantsStarted 2014-03-29

Plain-language summary

This randomized phase III trial studies exemestane and entinostat to see how well they work compared to exemestane alone in treating patients with hormone receptor-positive breast cancer that has spread to nearby tissue or lymph nodes (locally advanced) or another place in the body (metastatic). Estrogen can cause the growth of breast cancer cells. Endocrine therapy using exemestane may fight breast cancer by lowering the amount of estrogen the body makes. Entinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether exemestane is more effective with or without entinostat in treating breast cancer.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Estrogen receptor (ER) and/or progesterone receptor (PR) positive histologically confirmed adenocarcinoma of the breast with staining of \>= 1% cells will be considered positive; receptor status may be based on any time during treatment prior to study randomization, and from any site (i.e. primary, recurrent, or metastatic) * Patients whose tumors have HER2 immunohistochemistry (IHC) 3+, in situ hybridization (ISH) \>= 2.0, or average HER2 copy number \>= 6.0 signals per cell are not eligible; receptor status may be based on any time during treatment prior to study randomization, and from any site (i.e. primary, recurrent, or metastatic) * Patients must have measurable or non-measurable stage III/locally advanced or metastatic carcinoma of the breast where local therapy with curative intent is not possible; lesions must be evaluated =\< 4 weeks prior to study randomization; diagnostic-quality computed tomography (CT) scans with both oral and intravenous (IV) contrast are the expected radiologic method, unless an alternative is approved * NOTE: Where baseline imaging has already been performed =\< 6 weeks prior to study randomization, repeat imaging may not be required * NOTE: As of October 16, 2016, accrual of new patients having non-measurable disease has stopped; the planned accrual for this target population has been reached * Pre/peri- and postmenopausal women and all men are eligible for this trial; postmenopausal is defined as: * Age \>= 5…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This is a Phase 3 trial comparing exemestane alone versus exemestane plus entinostat — given that it's measuring both progression-free survival and overall survival, can you tell me whether any interim results have been shared publicly that might help us understand whether the combination is showing a real benefit?
2Since the trial is active but no longer enrolling new patients, does that change any of our options, and are there other similar trials combining a hormone therapy with an HDAC inhibitor like entinostat that I might still be eligible to join?
3Exemestane is already an approved hormonal therapy for hormone receptor-positive, HER2-negative breast cancer — how does starting exemestane on its own right now compare to waiting or seeking a trial that adds an experimental drug on top of it?
4Entinostat is an HDAC inhibitor, a type of drug that works differently from standard hormone therapy — what side effects or risks does adding this kind of drug typically bring, and how might those affect my day-to-day life if I were in a similar treatment approach?
5Given that my cancer is hormone receptor-positive and HER2-negative, are there other approved combination treatments — like CDK4/6 inhibitors — that I should be weighing against the approach being studied in this trial before we decide on a path forward?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Progression-free Survival (PFS)

Timeframe: Assessed at baseline, then every 12 weeks until treatment discontinuation, then every 3 months within 2 years from study entry, every 6 months between 2-5 years and annually between 6-10 years from study entry, until first disease progression

Overall Survival (OS)

Timeframe: Assessed every 3 months within 2 years from study entry, every 6 months between 2-5 years and annually between 6-10 years from study entry, until death

Trial details

NCT IDNCT02115282

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2020-05-05

Results submitted2021-08-04

View on ClinicalTrials.gov More Anatomic Stage III Breast Cancer AJCC v8 trials