OncRef

Clinical Trial: NCT01327781

Z-Endoxifen Hydrochloride in Treating Patients With Metastatic or Locally Recurrent Estrogen Receptor-Positive Breast Cancer

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 1

Lead Sponsor:National Cancer Institute (NCI)
Information Provided By:National Cancer Institute (NCI)
Last Update Posted:2026-08-25

Study Overview

Brief Summary

This phase I trial studies the side effects and the best dose of Z-endoxifen hydrochloride in treating patients with estrogen receptor-positive (ER+) breast cancer that has spread to other places in the body (metastatic) or has come back at or near the same place as the original tumor (locally recurrent). Estrogen can cause the growth of breast cancer cells. Hormone therapy using Z-endoxifen hydrochloride may fight breast cancer by blocking the use of estrogen by tumor cells.

Official Title

Phase I Study of Z-Endoxifen as a Hormonal Therapy for Breast Cancer

Conditions

HER2/Neu Positive, Recurrent Breast Carcinoma, Stage IIIC Breast Cancer AJCC v7, Stage IV Breast Cancer AJCC v6 and v7

Intervention / Treatment

  • Drug: Endoxifen Hydrochloride
  • Other: Laboratory Biomarker Analysis
  • Other: Pharmacological Study
  • Other: Questionnaire Administration

Other Study ID Numbers

  • NCI-2011-00847
  • NCI-2011-00847
  • CDR0000696902
  • MC093C
  • 8821
  • 8821
  • P30CA015083
  • P50CA116201
  • U01CA069912
  • UM1CA186686

Start Date (Actual)

2011-03-25

Primary Completion Date (Actual)

2017-03-05

Study Completion Date (Estimated)

2026-10-30

Enrollment (Actual)

62

Study Type

Interventional

Phase

Phase 1