A study that study if adding a hormone drug works better at using one drug only for Hormone Receptor-Positive Advanced Breast Cancer
New York Presbyterian Hospital Weill Cornell Medical Center: New York, New York, United States, 10065
Trial Summary
In this trial, researchers will study if stopping endocrine therapy to allow for pregnancy on women with breast cancer will make cancer come back. Endocrine therapy, also called hormone therapy, is a way to slow or stop breast cancer that is related to hormones. The study population is women undergoing endocrine therapy. All participants will stop endocrine therapy for around 2 years to allow pregnancy, delivery, breastfeeding etc.
Trial Design
608 participants will be recruited and randomly assigned into two groups. One group will receive both the Entinostat and Exemestane while the other group will receive Exemestane and placebo.
Inclusion Criteria
1. 18 years or older.
2. Currently have breast cancer stage III and satisfy cancer related conditions through lab tests.
3. All genders are eligible.
4. Must agree to use contraception or to abstain from sex for the duration of participation in the study and for 3 months after discontinuation of therapy.
5. Not currently pregnant or breastfeeding.
6. Other cancer related or general medical conditions that satisfy the study criteria.
Exclusion Criteria
1. Less than 18 years old.
2. Currently pregnant or breastfeeding.
Exclusion criteria are conditions or characteristics if they apply to you, may likely make you ineligible to participate in the study.
Inclusion criteria is a checklist of items, if they apply to you, may make you eligible to be included for the study.