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NCT00217399 · ClinicalTrials.gov registry record · Phase 1
Sorafenib and Anastrozole in Treating Postmenopausal Women With Metastatic Breast Cancer
A Phase 1 study of Stage IV Breast Cancer and Recurrent Breast Cancer, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
- 1
- Study location
NCT00217399: Completed Phase 1 study of Stage IV Breast Cancer and Recurrent Breast Cancer, sponsored by National Cancer Institute (NCI).
NCT00217399 is a Phase 1 study of Stage IV Breast Cancer and Recurrent Breast Cancer that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 35 participants, below the 65-participant average among 30 other Stage IV Breast Cancer trials with a reported enrollment target (46% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00217399, a Phase 1 study of Stage IV Breast Cancer and Recurrent Breast Cancer, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
- 1
- Study location
Study Summary
Sorafenib may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. Estradiol can cause the growth of breast cancer. Hormone therapy using anastrozole may fight breast cancer by blocking the use of estradiol by the tumor cells. Sometimes when hormone therapy is given, it does not stop the growth of tumor cells. The tumor is said to be resistant to hormone therapy. Giving sorafenib together with anastrozole may reduce drug resistance and allow the tumor cells to be killed. This phase I/II trial is studying the side effects and best dose of sorafenib when given in combination with anastrozole and to see how well they work in treating postmenopausal women with metastatic breast cancer.
Primary Outcome
Clinical Outcome measured using Response Evaluation Criteria In Solid Tumors (RECIST,)V1.0, and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), a tumor that is neither growing nor shrinking. A patient has clinical benefit from treatment if CR + PR + SD \> 24 weeks.
Conditions Studied
Interventions
- DRUG anastrozole
- DRUG sorafenib tosylate
Study Locations (1)
District of Columbia
- Lombardi Comprehensive Cancer Center at Georgetown University - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2005-06 |
| Est. Completion | 2013-01 |
| Phase | Phase 1 |
What the finished NCT00217399 record still lists
NCT00217399 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 65-participant average among 30 other Stage IV Breast Cancer trials with a reported enrollment target (46% lower).
The record links to 2 conditions, with Stage IV Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which anastrozole is the first listed.
NCT00217399 reports a single indexed study location in District of Columbia.
Frequently Asked Questions
What is clinical trial NCT00217399 about?
NCT00217399 is a clinical study titled "Sorafenib and Anastrozole in Treating Postmenopausal Women With Metastatic Breast Cancer". Sorafenib may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. Estradiol can cause the growth of breast cancer. Hormone therapy using anastrozole may fight breast cancer by blocking the use of estradiol by the tumor cells....
What is the current status of trial NCT00217399?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2005-06. Estimated completion is 2013-01.
What conditions does trial NCT00217399 study?
This clinical trial studies the following conditions: Stage IV Breast Cancer, Recurrent Breast Cancer.
What interventions are being tested in trial NCT00217399?
The interventions under investigation include: anastrozole (DRUG), sorafenib tosylate (DRUG).
Who is sponsoring clinical trial NCT00217399?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00217399 being conducted?
This trial has 1 study location across District of Columbia. 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 NCT00217399's enrollment target sits among peer trials
35 11th of 30 higher than 19 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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