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NCT02311933 · ClinicalTrials.gov registry record · Phase 2
Tamoxifen Citrate or Z-Endoxifen Hydrochloride in Treating Patients With Locally Advanced or Metastatic, Estrogen Receptor-Positive, HER2-Negative Breast Cancer
A Phase 2 study of Recurrent Breast Carcinoma and Stage IV Breast Cancer AJCC v6 and v7, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 81
- Enrollment target
- 20
- Study locations
NCT02311933: Active Phase 2 study of Recurrent Breast Carcinoma and Stage IV Breast Cancer AJCC v6 and v7, sponsored by National Cancer Institute (NCI).
NCT02311933 is a Phase 2 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 81 participants, below the 288-participant average among 29 other Recurrent Breast Carcinoma trials with a reported enrollment target (72% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02311933, a Phase 2 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 2
- Development phase
- 81 participants
- Enrollment target
- 20
- Study locations
Study Summary
This randomized phase II trial studies how well tamoxifen citrate works compared with z-endoxifen hydrochloride in treating patients with breast cancer that has spread to nearby tissue or lymph nodes or other parts of the body and has estrogen receptors but not human epidermal growth factor receptor 2 (HER2) receptors on the surface of its cells. Estrogen can cause the growth of tumor cells. Hormone therapy using tamoxifen citrate or z-endoxifen hydrochloride may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet known whether tamoxifen citrate or z-endoxifen hydrochloride is more effective in treating patients with breast cancer.
Primary Outcome
The primary endpoint is progression-free survival (PFS) defined as the time from randomization to documentation of local, regional or distant disease progression or death without progression of disease.
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Endoxifen Hydrochloride
- DRUG Tamoxifen Citrate
- OTHER Pharmacological Study
Study Locations (20)
Alaska
- Anchorage Associates in Radiation Medicine - Anchorage
- Anchorage Radiation Therapy Center - Anchorage
- Alaska Breast Care and Surgery LLC - Anchorage
- Alaska Oncology and Hematology LLC - Anchorage
- Alaska Regional Hospital - Anchorage
- Alaska Women's Cancer Care - Anchorage
- Anchorage Oncology Centre - Anchorage
- Katmai Oncology Group - Anchorage
- Providence Alaska Medical Center - Anchorage
- Fairbanks Memorial Hospital - Fairbanks
California
- Kaiser Permanente-Anaheim - Anaheim
- PCR Oncology - Arroyo Grande
- Sutter Auburn Faith Hospital - Auburn
- Sutter Cancer Centers Radiation Oncology Services-Auburn - Auburn
- AIS Cancer Center at San Joaquin Community Hospital - Bakersfield
Arizona
- Mayo Clinic Hospital in Arizona - Phoenix
- Mayo Clinic in Arizona - Scottsdale
Arkansas
- CHI Saint Vincent Cancer Center Hot Springs - Hot Springs
- NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro - Jonesboro
Alabama
- Southern Cancer Center PC-Providence - Mobile
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2015-05-28 |
| Est. Completion | 2027-02-02 |
| Phase | Phase 2 |
What the registry record for NCT02311933 still lists
NCT02311933 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, below the 288-participant average among 29 other Recurrent Breast Carcinoma trials with a reported enrollment target (72% lower).
The record links to 6 conditions, with Recurrent Breast Carcinoma appearing as the primary indexed condition, and to 4 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT02311933 names 20 study sites across 5 states, led by Alaska, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT02311933 about?
NCT02311933 is a clinical study titled "Tamoxifen Citrate or Z-Endoxifen Hydrochloride in Treating Patients With Locally Advanced or Metastatic, Estrogen Receptor-Positive, HER2-Negative Breast Cancer". This randomized phase II trial studies how well tamoxifen citrate works compared with z-endoxifen hydrochloride in treating patients with breast cancer that has spread to nearby tissue or lymph nodes or other parts of the body and has estrogen receptors but not human epidermal growth factor receptor...
What is the current status of trial NCT02311933?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 81 participants. The study started on 2015-05-28. Estimated completion is 2027-02-02.
What conditions does trial NCT02311933 study?
This clinical trial studies the following conditions: Recurrent Breast Carcinoma, Stage IV Breast Cancer AJCC v6 and v7, Stage III Breast Cancer AJCC v7, Stage IIIC Breast Cancer AJCC v7, Stage IIIA Breast Cancer AJCC v7.
What interventions are being tested in trial NCT02311933?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Endoxifen Hydrochloride (DRUG), Tamoxifen Citrate (DRUG), Pharmacological Study (OTHER).
Who is sponsoring clinical trial NCT02311933?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02311933 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Recurrent Breast Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02311933's enrollment target sits among peer trials
81 9th of 29 higher than 21 of 29 other Recurrent Breast Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Breast Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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