NCT02820961 is a Phase 1 clinical trial of entinostat in Breast Cancer, sponsored by Syndax Pharmaceuticals.

Who is sponsoring NCT02820961?

NCT02820961 is sponsored by Syndax Pharmaceuticals.

What drugs are being tested in NCT02820961?

Interventions in NCT02820961: entinostat, exemestane.

What condition does NCT02820961 study?

NCT02820961 studies Breast Cancer, Estrogen Receptor Positive Breast Cancer.

Is NCT02820961 still recruiting?

NCT02820961 is currently completed. Last updated 15 December 2021.

Last reviewed 2021-12-15 · How we verify

NCT02820961

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Drug-Drug Interaction Study of Entinostat and Exemestane in Postmenopausal Women With ER+ Breast Cancer

Completed Phase 1 Last updated 15 December 2021

What this trial tests

Phase 1 trial testing entinostat in Breast Cancer in 61 participants. Completed in 12 July 2021.

Timeline

29 June 2016

Primary endpoint
10 September 2018

12 July 2021

Quick facts

Lead sponsor	Syndax Pharmaceuticals
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	61
Start date	29 June 2016
Primary completion	10 September 2018
Estimated completion	12 July 2021
Sites	3 locations across United States

Drugs / interventions tested

entinostat — full drug profile →
exemestane (exemestane) — full drug profile →

Conditions studied

Breast Cancer — all drugs for Breast Cancer →
Estrogen Receptor Positive Breast Cancer — all drugs for Estrogen Receptor Positive Breast Cancer →

Sponsor

Syndax Pharmaceuticals — full company profile →

Who can join

Adults 18 to 85, female only, with Breast Cancer or Estrogen Receptor Positive Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to determine the effect of exemestane on the pharmacokinetics (PK) of entinostat and to determine the effect of entinostat on the PK of exemestane in patients with locally recurrent or metastatic estrogen receptor positive (ER+) breast cancer. Additionally, this study will evaluate the safety and tolerability of entinostat in combination with exemestane, and assess the effectiveness of entinostat in combination with exemestane in terms of best overall response and overall survival.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Cancer epigenetics: Moving forward.
Nebbioso A, Tambaro FP, Dell'Aversana C, Altucci L. · · 2018 · cited 325× · PMID 29879107 · DOI 10.1371/journal.pgen.1007362
Epigenetic mechanisms in breast cancer therapy and resistance.
Garcia-Martinez L, Zhang Y, Nakata Y, Chan HL, et al · · 2021 · cited 319× · PMID 33741974 · DOI 10.1038/s41467-021-22024-3
Endocrine Resistance in Hormone Receptor Positive Breast Cancer-From Mechanism to Therapy.
Rani A, Rani A, Stebbing J, Giamas G, et al · · 2019 · cited 162× · PMID 31178825 · DOI 10.3389/fendo.2019.00245
Epigenetics-targeted drugs: current paradigms and future challenges.
Dai W, Qiao X, Fang Y, Guo R, et al · · 2024 · cited 131× · PMID 39592582 · DOI 10.1038/s41392-024-02039-0
Regulation and signaling pathways in cancer stem cells: implications for targeted therapy for cancer.
Zeng Z, Fu M, Hu Y, Wei Y, et al · · 2023 · cited 93× · PMID 37853437 · DOI 10.1186/s12943-023-01877-w
Targeting epigenetic regulators as a promising avenue to overcome cancer therapy resistance.
Song J, Yang P, Chen C, Ding W, et al · · 2025 · cited 40× · PMID 40675967 · DOI 10.1038/s41392-025-02266-z
Harnessing Epigenetics for Breast Cancer Therapy: The Role of DNA Methylation, Histone Modifications, and MicroRNA.
Szczepanek J, Skorupa M, Jarkiewicz-Tretyn J, Cybulski C, et al · · 2023 · cited 30× · PMID 37108398 · DOI 10.3390/ijms24087235
Short-chain acyl post-translational modifications in cancers: Mechanisms, roles, and therapeutic implications.
Wu T, Zhao Y, Zhang X, Wang Y, et al · · 2025 · cited 23× · PMID 40703012 · DOI 10.1002/cac2.70048

Verify or expand the search:

Other trials of entinostat

Trials testing the same drug.

NCT07330544 — A Phase II Clinical Study Evaluating Entinostat With or Without Anlotinib + Fulvestrant for the Treatment of Hormone Rec · Phase 2 · recruiting
NCT07492394 — Dalpiciclib With or Without Entinostat and Letrozole in HR+/HER2- Early Breast Cancer · Phase 2 · recruiting
NCT03215264 — To Determine the Safety of Regorafenib, Hydroxychloroquine, and Entinostat Metastatic Colorectal Cancer · Phase 1 · completed
NCT02915523 — Study of Avelumab With or Without Entinostat in Participants With Advanced Epithelial Ovarian Cancer · Phase 1, PHASE2 · completed
NCT02922933 — A Study to Examine the Effect of Omeprazole, Famotidine, and an Acidic Beverage on the Pharmacokinetics of Entinostat in · Phase 1 · completed

Other recruiting trials for Breast Cancer

Currently open trials in the same condition.

NCT06148038 — CBD for Breast Cancer Primary Tumors · Phase 1 · recruiting
NCT07405801 — A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus R · Phase 2 · recruiting
NCT07285993 — Detection and Outcomes in Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAP PET · Phase 2 · recruiting
NCT07510698 — Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer · NA · recruiting
NCT06768931 — Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer · Phase 2 · recruiting

Other Syndax Pharmaceuticals trials

Trials by the same sponsor.

NCT05731947 — Evaluation of Revumenib in Participants With Colorectal Cancer and Other Solid Tumors · Phase 1, PHASE2 · completed
NCT05406817 — Study of Radiolabeled Revumenib in Adults With Acute Leukemia · Phase 1 · completed
NCT05326516 — A Study of Revumenib in Combination With Chemotherapy in Participants With R/R Acute Leukemia · Phase 1 · completed
NCT04415073 — A Phase 2 Study to Evaluate Axatilimab for Hospitalized Participants With Respiratory Involvement Secondary to COVID-19 · Phase 2 · terminated
NCT04065399 — A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation · Phase 1, PHASE2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02820961 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Syndax Pharmaceuticals
Last refreshed: 15 December 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02820961.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing