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NCT01385280 · ClinicalTrials.gov registry record · NA
Pilot Study Estradiol Followed by Exemestane Hormone Receptor + Metastatic Breast Cancer
A NA study of Stage IV Breast Cancer and Stage IIIC Breast Cancer, sponsored by University of Arizona.
- Completed
- Registry status
- NA
- Development phase
- 13
- Enrollment target
- 1
- Study location
NCT01385280: Completed NA study of Stage IV Breast Cancer and Stage IIIC Breast Cancer, sponsored by University of Arizona.
NCT01385280 is a NA study of Stage IV Breast Cancer and Stage IIIC Breast Cancer that has completed, run by University of Arizona. The registered enrollment target is 13 participants, below the 66-participant average among 30 other Stage IV Breast Cancer trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01385280, a NA study of Stage IV Breast Cancer and Stage IIIC Breast Cancer, has completed, sponsored by University of Arizona.
- COMPLETED
- Registry status
- NA
- Development phase
- 13 participants
- Enrollment target
- 1
- Study location
Study Summary
RATIONALE: Estrogen can cause the growth of tumor cells. Hormone therapy using therapeutic estradiol may fight breast cancer by lowering the amount of estrogen the body makes. Though estradiol initially produces stimulation of ER+ cancer cells, both laboratory and some clinical experience indicate that it may have the opposite effect on such cells, once they have become resistant to estrogen deprivation. In laboratory models, there is death of the "resistant" population after estradiol treatment, followed by restoration of sensitivity of the remaining cells to estrogen deprivation, as with an aromatase inhibitor. Exemestane may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving therapeutic estradiol together with exemestane may kill more tumor cells. PURPOSE: This clinical trial studies therapeutic estradiol and exemestane in treating post-menopausal patients with hormone receptor-positive metastatic breast cancer
Primary Outcome
Such as deep vein thrombosis requiring hospitalization or pulmonary embolism
Conditions Studied
Interventions
- OTHER laboratory biomarker analysis
- DRUG exemestane
- BIOLOGICAL therapeutic estradiol
- OTHER enzyme-linked immunosorbent assay
Study Locations (1)
Arizona
- University of Arizona Cancer Center - Tucson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2011-02 |
| Est. Completion | 2013-10 |
| Phase | NA |
What the finished NCT01385280 record still lists
NCT01385280 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 66-participant average among 30 other Stage IV Breast Cancer trials with a reported enrollment target (80% lower).
The record links to 5 conditions, with Stage IV Breast Cancer appearing as the primary indexed condition, and to 4 interventions - of which laboratory biomarker analysis is the first listed.
NCT01385280 reports a single indexed study location in Arizona.
Frequently Asked Questions
What is clinical trial NCT01385280 about?
NCT01385280 is a clinical study titled "Pilot Study Estradiol Followed by Exemestane Hormone Receptor + Metastatic Breast Cancer". RATIONALE: Estrogen can cause the growth of tumor cells. Hormone therapy using therapeutic estradiol may fight breast cancer by lowering the amount of estrogen the body makes. Though estradiol initially produces stimulation of ER+ cancer cells, both laboratory and some clinical experience indicate t...
What is the current status of trial NCT01385280?
This trial is currently completed. It is a NA study. The enrollment target is 13 participants. The study started on 2011-02. Estimated completion is 2013-10.
What conditions does trial NCT01385280 study?
This clinical trial studies the following conditions: Stage IV Breast Cancer, Stage IIIC Breast Cancer, Recurrent Breast Cancer, Estrogen Receptor-positive Breast Cancer, Progesterone Receptor Positive Tumor.
What interventions are being tested in trial NCT01385280?
The interventions under investigation include: laboratory biomarker analysis (OTHER), exemestane (DRUG), therapeutic estradiol (BIOLOGICAL), enzyme-linked immunosorbent assay (OTHER).
Who is sponsoring clinical trial NCT01385280?
This trial is sponsored by University of Arizona, which has 349 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01385280 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stage IV Breast Cancer
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 NCT01385280's enrollment target sits among peer trials
13 29th of 30 higher than 2 of 30 other Stage IV Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage IV Breast Cancer 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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