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NCT00256217 · ClinicalTrials.gov registry record · Phase 2
Chemoprevention Trial - Anastrozole in Ductal Carcinoma In Situ (DCIS) in Postmenopausal Women
A Phase 2 study of DCIS, sponsored by Rita Sanghvi, Mehta.
- Completed
- Registry status
- Phase 2
- Development phase
- 42
- Enrollment target
- 1
- Study location
NCT00256217: Completed Phase 2 study of DCIS, sponsored by Rita Sanghvi, Mehta.
NCT00256217 is a Phase 2 study of DCIS that has completed, run by Rita Sanghvi, Mehta. The registered enrollment target is 42 participants, below the 564-participant average among 9 other DCIS trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00256217, a Phase 2 study of DCIS, has completed, sponsored by Rita Sanghvi, Mehta.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 42 participants
- Enrollment target
- 1
- Study location
Study Summary
Breast cancer is one of the most common cancers seriously afflicting women in the United States. Of the one million incident cases that are reported annually there are approximately 193,000 new cases of breast cancer (Greenlee, 2001). Although significant advances have been made both in early detection and treatment of breast cancer, the impact of these on reduction in mortality has been modest (Peta, 2000). Furthermore, despite data implicating diet and other environmental risk factors, no lifestyle changes have yet been shown to significantly reduce the risk of breast cancer. Therefore, chemoprevention of breast cancer is a worthwhile approach to reduce the incidence of breast cancer. There is every reason to believe that a detailed understanding of the initiation, promotion and growth of breast cancer will ultimately provide a rational strategy upon which to base prevention strategies. While the pathways of breast cancer development are not yet fully understood, a role for estrogens in breast cancer etiology has been well established. While many pathways are involved in breast cancer etiology, including loss of tumor suppressor function by p53 or BRCA1 and gain of HER2 oncogene expression, their exact role in an individual patient's cancer development may vary. Therefore, it may be advantageous to focus on a chemoprevention strategy that may have a more uniform impact on breast cancer development, such as estrogen exposure. Estrogen and its metabolites, both in the circulation and locally synthesized in the breast, are important in the pathogenesis of breast cancer. High levels of circulating estrogen in postmenopausal women have been associated with an increased risk of breast cancer (Clemons, 2001). Furthermore, local estrogen synthesis, i.e. aromatase activity, in the breast may also be important in the development of breast cancer.
Conditions Studied
Interventions
- DRUG Anastrozole
Study Locations (1)
California
- Chao Family Comprehensive Cancer Center - Orange
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2004-09-21 |
| Est. Completion | 2018-12-12 |
| Phase | Phase 2 |
What the finished NCT00256217 record still lists
NCT00256217 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 564-participant average among 9 other DCIS trials with a reported enrollment target (93% lower).
The record links to 1 condition, with DCIS appearing as the primary indexed condition, and to 1 intervention - of which Anastrozole is the first listed.
NCT00256217 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT00256217 about?
NCT00256217 is a clinical study titled "Chemoprevention Trial - Anastrozole in Ductal Carcinoma In Situ (DCIS) in Postmenopausal Women". Breast cancer is one of the most common cancers seriously afflicting women in the United States. Of the one million incident cases that are reported annually there are approximately 193,000 new cases of breast cancer (Greenlee, 2001). Although significant advances have been made both in early detect...
What is the current status of trial NCT00256217?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 2004-09-21. Estimated completion is 2018-12-12.
What conditions does trial NCT00256217 study?
This clinical trial studies the following conditions: DCIS.
What interventions are being tested in trial NCT00256217?
The interventions under investigation include: Anastrozole (DRUG).
Who is sponsoring clinical trial NCT00256217?
This trial is sponsored by Rita Sanghvi, Mehta, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00256217 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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