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NCT00754325 · ClinicalTrials.gov registry record · Phase 2
Randomized Trial of Fulvestrant With or Without Dasatinib in Men and Postmenopausal Women Who Have Hormone Receptor-positive Advanced Breast Cancer Previously Treated With an Aromatase Inhibitor
A Phase 2 study of Advanced Breast Cancer, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
- 20
- Study locations
NCT00754325: Completed Phase 2 study of Advanced Breast Cancer, sponsored by Bristol-Myers Squibb.
NCT00754325 is a Phase 2 study of Advanced Breast Cancer that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 100 participants, below the 461-participant average among 28 other Advanced Breast Cancer trials with a reported enrollment target (78% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00754325, a Phase 2 study of Advanced Breast Cancer, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to find out what effect the combination of fulvestrant (Faslodex) and dasatinib (Sprycel) has on advanced breast cancer compared to fulvestrant alone.
Primary Outcome
This endpoint evaluated the progression free survival (PFS) of participants amongst the total evaluable population. Progression free survival (PFS) was defined as the time from randomization to either the date the subject was first recorded as having PD (even if the subject went off treatment because of toxicity), or the date of death if the subject died due to any causes before progression. Participants with no recorded post-baseline tumor assessment had PFS censored at the day of randomization
Conditions Studied
Interventions
- DRUG Fulvestrant
- DRUG Dasatinib
Study Locations (20)
Texas
- Texas Oncology-Central Austin Cancer Center - Austin
- Texas Oncology, P.A. - Bedford
- Texas Oncology, P.A. - Dallas
- Texas Oncology - Dallas
- Texas Oncology Sammons Cancer Center - Dallas
- Texas Cancer Center - Denton
- El Paso Cancer Treatment Ctr - West - El Paso
- Us Oncology Research, Inc. - Houston
Arizona
- Northern Arizona Hematology & Oncology Associates - Sedona
- Arizona Oncol Assoc Dba (Hem Onc Physicians&Extenders) Hope - Tucson
Florida
- Florida Cancer Institute - New Hope - Hudson
- Cancer Centers Of Florida, P.A - Ocoee
Oregon
- Willamette Valley Cancer Center - Eugene
- Northwest Cancer Specialists, P.C. - Portland
Indiana
- Central Indiana Cancer Centers - Carmel
Kansas
- Kansas City Cancer Center, Llc. - Overland Park
Minnesota
- Minnesota Oncology Hematology, P.A. - Minneapolis
Missouri
- Missouri Cancer Associates - Columbia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2008-09 |
| Est. Completion | 2014-01 |
| Phase | Phase 2 |
What the finished NCT00754325 record still lists
NCT00754325 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 461-participant average among 28 other Advanced Breast Cancer trials with a reported enrollment target (78% lower).
The record links to 1 condition, with Advanced Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Fulvestrant is the first listed.
NCT00754325 names 20 study sites across 10 states, led by Texas, Arizona, Florida.
Frequently Asked Questions
What is clinical trial NCT00754325 about?
NCT00754325 is a clinical study titled "Randomized Trial of Fulvestrant With or Without Dasatinib in Men and Postmenopausal Women Who Have Hormone Receptor-positive Advanced Breast Cancer Previously Treated With an Aromatase Inhibitor". The purpose of this study is to find out what effect the combination of fulvestrant (Faslodex) and dasatinib (Sprycel) has on advanced breast cancer compared to fulvestrant alone.
What is the current status of trial NCT00754325?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2008-09. Estimated completion is 2014-01.
What conditions does trial NCT00754325 study?
This clinical trial studies the following conditions: Advanced Breast Cancer.
What interventions are being tested in trial NCT00754325?
The interventions under investigation include: Fulvestrant (DRUG), Dasatinib (DRUG).
Who is sponsoring clinical trial NCT00754325?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00754325 being conducted?
This trial has 20 study locations across Arizona, Florida, Indiana, Kansas, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Advanced 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 NCT00754325's enrollment target sits among peer trials
100 21st of 28 higher than 8 of 28 other Advanced Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Advanced 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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