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NCT01327781 · ClinicalTrials.gov registry record · Phase 1
Z-Endoxifen Hydrochloride in Treating Patients With Metastatic or Locally Recurrent Estrogen Receptor-Positive Breast Cancer
A Phase 1 study of Recurrent Breast Carcinoma and Stage IV Breast Cancer AJCC v6 and v7, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 62
- Enrollment target
- 3
- Study locations
NCT01327781: Active Phase 1 study of Recurrent Breast Carcinoma and Stage IV Breast Cancer AJCC v6 and v7, sponsored by National Cancer Institute (NCI).
NCT01327781 is a Phase 1 study of Recurrent Breast Carcinoma and Stage IV Breast Cancer AJCC v6 and v7 that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 62 participants, below the 288-participant average among 29 other Recurrent Breast Carcinoma trials with a reported enrollment target (78% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01327781, a Phase 1 study of Recurrent Breast Carcinoma and Stage IV Breast Cancer AJCC v6 and v7, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 62 participants
- Enrollment target
- 3
- Study locations
Study 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.
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- OTHER Questionnaire Administration
- DRUG Endoxifen Hydrochloride
- OTHER Pharmacological Study
Study Locations (3)
Arizona
- Mayo Clinic in Arizona - Scottsdale
Florida
- Mayo Clinic in Florida - Jacksonville
Minnesota
- Mayo Clinic in Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 62 participants |
| Start Date | 2011-03-25 |
| Est. Completion | 2026-10-30 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01327781
The ClinicalTrials.gov registry entry for NCT01327781 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 62 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 288-participant average among 29 other Recurrent Breast Carcinoma trials with a reported enrollment target (78% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Recurrent Breast Carcinoma appearing as the primary indexed condition, and to 4 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT01327781 reports 3 study locations spanning 3 distinct geographic areas - top geographies include Arizona, Florida, Minnesota.
Frequently Asked Questions
What is clinical trial NCT01327781 about?
NCT01327781 is a clinical study titled "Z-Endoxifen Hydrochloride in Treating Patients With Metastatic or Locally Recurrent Estrogen Receptor-Positive Breast Cancer". 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 recur...
What is the current status of trial NCT01327781?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 62 participants. The study started on 2011-03-25. Estimated completion is 2026-10-30.
What conditions does trial NCT01327781 study?
This clinical trial studies the following conditions: Recurrent Breast Carcinoma, Stage IV Breast Cancer AJCC v6 and v7, Stage IIIC Breast Cancer AJCC v7, HER2/Neu Positive.
What interventions are being tested in trial NCT01327781?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Questionnaire Administration (OTHER), Endoxifen Hydrochloride (DRUG), Pharmacological Study (OTHER).
Who is sponsoring clinical trial NCT01327781?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01327781 being conducted?
This trial has 3 study locations across Arizona, Florida, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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