Clinical Trials Logo
  1. Home
  2. Advanced Breast Cancer
  3. NCT03538171

Ph3 Study of Exemestane With or Without Entinostat in Chinese Patients With Hormone Receptor-Positive, Locally Advanced or Metastatic Breast Cancer

Advanced Breast Cancer Clinical Trial

Official title:
A Randomized Phase III Clinical Study of Entinostat/Placebo in Combination With Exemestane in Chinese Patients With Hormone Receptor-positive Advanced Breast Cancer

Clinical Trial Summary

The purpose of this randomized phase III trial is to evaluate the clinical benefit of combining entinostat with exemestane in Chinese patients with HR-positive, HER2-negative, locally advanced or metastatic breast cancer, who have disease progression on endocrine therapy. Additionally，the safety, tolerability, and PK profile of the treatment combination are evaluated.

Clinical Trial Description

This randomized phase III trial studies entinostat combination with exemestane to see how well they work compared to exemestane alone in treating Chinese patients with hormone receptor-positive, locally advanced or metastatic breast cancers. Estrogen can drive the growth of breast cancer cells. Exemestane may fight breast cancer by lowering the amount of estrogen the body makes from tissue aromatase. Entinostat may enhance the anti-tumor effect of exemestane in breast cancer by helping to overcome tumor resistance via epigenetic modifications. Previous Phase II trial in US breast cancer patients have demonstrated significant effects of combined therapy in slowing disease progression and on patient survival when compared to exemestane alone. It is not yet known whether exemestane is more effective when combined with entinostat in Chinese patients with advanced breast cancer. In this parallel, randomized, double blind, active controlled study, we will study the effect of entinostat/placebo in combination with exemestane in Chinese patients with hormone receptor-positive, HER2 receptor-negative, locally advance or metastatic breast cancer, who have experienced disease progression with prior endocrine therapies. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03538171
Study type Interventional
Source Taizhou EOC Pharma Co., Ltd.
Contact
Status Active, not recruiting
Phase Phase 3
Start date May 15, 2018
Completion date March 2023
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT04653740 - Omic Technologies to Track Resistance to Palbociclib in Metastatic Breast Cancer N/A
Completed NCT02091960 - A Study to Assess the Efficacy and Safety of Enzalutamide With Trastuzumab in Patients With Human Epidermal Growth Factor Receptor 2 Positive (HER2+), Androgen Receptor Positive (AR+) Metastatic or Locally Advanced Breast Cancer Phase 2
Recruiting NCT05156619 - Health Care Disparities in Culturally Diverse, Special Needs & Disadvantaged Populations - Bridging the Gap
Recruiting NCT05173103 - Retrospective Study of 2nd-line Therapies After CDK4/6i + Hormonal Therapy in HR+/HER2- Advanced Breast Cancer
Withdrawn NCT05191004 - Study of NUV-422 in Combination With Fulvestrant in Patients With HR+HER2- aBC Phase 1/Phase 2
Completed NCT00754325 - Randomized Trial of Fulvestrant With or Without Dasatinib in Men and Postmenopausal Women Who Have Hormone Receptor-positive Advanced Breast Cancer Previously Treated With an Aromatase Inhibitor Phase 2
Recruiting NCT04953377 - PFMT Educational Intervention for Patients With Advancer Breast Cancer N/A
Completed NCT03240224 - Bioinformation Therapy for Breast Cancer Phase 2/Phase 3
Recruiting NCT06193525 - FUnctional Selection of Advanced Breast Cancer Patients for Talazoparib Treatment Using the REpair Capacity (RECAP) Test Phase 2
Completed NCT03312738 - A Study of Everolimus Plus Exemestane in Chinese Postmenopausal Women With Estrogen Receptor Positive, Locally Advanced, Recurrent, or Metastatic Breast Cancer After Recurrence or Progression on Non-steroidal Aromatase Inhibitor Phase 2
Active, not recruiting NCT05063786 - Trastuzumab + Alpelisib +/- Fulvestrant vs Trastuzumab + CT in Patients With PIK3CA Mutated Previously Treated HER2+ Advanced BrEasT Cancer (ALPHABET) Phase 3
Recruiting NCT05655598 - TAS-116 Plus Palbociclib in Breast and Rb-null Cancer Phase 1
Active, not recruiting NCT02499146 - Palbociclib Pharmacokinetics Study In Postmenopausal Chinese Women With ER (+), HER2 (-) Advanced Breast Cancer Phase 1
Completed NCT00445458 - A Phase 1/2 Study of HKI-272 (Neratinib) in Combination With Paclitaxel (Taxol) in Subjects With Solid Tumors and Breast Cancer Phase 1/Phase 2
Recruiting NCT04456855 - Locoregional Surgery of the Primary Tumor in de Novo Stage IV Breast Cancer Patients
Completed NCT04408118 - First Line Atezolizumab, Paclitaxel, and Bevacizumab (Avastin®) in mTNBC Phase 2
Recruiting NCT04222413 - Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors Phase 1
Completed NCT03205761 - Analysis of Olaparib Response in Patients With BRCA1 and/or 2 Promoter Methylation Diagnosed of Advanced Breast Cancer Phase 2
Withdrawn NCT04316169 - Hydroxychloroquine, Abemaciclib and Endocrine Therapy in Hormone Receptor Positive (HR+)/Her 2 Negative Breast Cancer Phase 1
Completed NCT00546104 - Phase II Dasatinib Study in Advanced Breast Cancer Phase 2