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Endoxifen Hydrochloride

DRUG3 trials

Sponsors

National Cancer Institute (NCI)

Conditions

Breast Carcinoma In SituBreast Ductal Carcinoma In SituBreast Lobular Carcinoma In SituHER2/Neu PositiveRecurrent Breast CarcinomaStage I Breast Cancer AJCC v7Stage IA Breast Cancer AJCC v7Stage IB Breast Cancer AJCC v7

Phase 1

Z-Endoxifen Hydrochloride in Treating Patients With Metastatic or Locally Recurrent Estrogen Receptor-Positive Breast Cancer
Active, not recruitingNCT01327781
National Cancer Institute (NCI)HER2/Neu Positive, Recurrent Breast Carcinoma, Stage IIIC Breast Cancer AJCC v7 +1
Start: 2011-03-25End: 2026-10-30Updated: 2026-08-25
Phase I Trial of Endoxifen Gel Versus Placebo in Women Undergoing Breast Surgery
Active, not recruitingNCT03317405
National Cancer Institute (NCI)Breast Carcinoma In Situ, Breast Ductal Carcinoma In Situ, Breast Lobular Carcinoma In Situ +10
Start: 2018-10-31End: 2027-08-12Updated: 2026-09-02

Phase 2

Tamoxifen Citrate or Z-Endoxifen Hydrochloride in Treating Patients With Locally Advanced or Metastatic, Estrogen Receptor-Positive, HER2-Negative Breast Cancer
Active, not recruitingNCT02311933
National Cancer Institute (NCI)Recurrent Breast Carcinoma, Stage IIIA Breast Cancer AJCC v7, Stage IIIB Breast Cancer AJCC v7 +3
Start: 2015-05-28End: 2027-02-02Updated: 2026-08-28

Related Papers

Abstract PS1-08-07: Final results from the Randomized Phase II study of Z-Endoxifen and Tamoxifen in Endocrine Refractory, Estrogen Receptor Positive, HER2 negative Metastatic Breast Cancer (Alliance A011203)
Clinical Cancer Research2026-02-17
Abstract PD7-06: A randomized phase II trial of tamoxifen versus Z-endoxifen HCL in postmenopausal women with metastatic estrogen receptor positive, HER2 negative breast cancer
Cancer Research2020-02-155 citations
Phase I trial of endoxifen gel versus placebo gel in women undergoing breast surgery.
Journal of Clinical Oncology2019-05-20
Evaluation of tumor and circulating cell free (cf) DNA mutations in women with hormone refractory metastatic breast cancer (MBC) enrolled in a phase I study of Z-endoxifen (MC093C).
Journal of Clinical Oncology2017-05-20
Abstract PD2-03: Final results of a first-in-human phase I study of the tamoxifen (TAM) metabolite, Z-Endoxifen hydrochloride (Z-Endx) in women with aromatase inhibitor (AI) refractory metastatic breast cancer (MBC) (NCT01327781)
Cancer Research2016-02-151 citations