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NCT00656669 · ClinicalTrials.gov registry record · NA
Exploratory Study of Sunitinib Malate as a Component of Neoadjuvant Therapy for Breast Cancer
A NA study, sponsored by Indiana University.
- Completed
- Registry status
- NA
- Development phase
- 23
- Enrollment target
NCT00656669: Completed NA study, sponsored by Indiana University.
NCT00656669 is a NA study that has completed, run by Indiana University. The registered enrollment target is 23 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00656669, a NA study, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- NA
- Development phase
- 23 participants
- Enrollment target
Study Summary
The combination of paclitaxel, doxorubicin, and cyclophosphamide is a standard neoadjuvant (given before surgery) treatment for patients that have either inoperable or operable breast cancer. This treatment can help shrink the tumors so they can be removed to help prevent the cancer from spreading to other parts of the body. This study is being done to test the impact of adding sunitinib as a single-agent (Segment 1), followed by sunitinib plus paclitaxel (Segment 2), followed by doxorubicin and cyclophosphamide (Segment 3). We hope the addition of sunitinib will make the treatment more effective, but we don't know if this is true.
Primary Outcome
Participants had their tumor IFP measured at baseline, after sunitinib monotherapy (segment 1) and after sunitinib+paclitaxel (segment 2). This outcome measure is the difference of the mean value from the end of segment 1 (sunitinib monotherapy) and the mean baseline value.
Interventions
- DRUG sunitinib alone
- DRUG sunitinib plus paclitaxel
- DRUG doxorubicin and cyclophosphamide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2008-04 |
| Est. Completion | 2010-09 |
| Phase | NA |
What the finished NCT00656669 record still lists
NCT00656669 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 3 interventions - of which sunitinib alone is the first listed.
NCT00656669 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00656669 about?
NCT00656669 is a clinical study titled "Exploratory Study of Sunitinib Malate as a Component of Neoadjuvant Therapy for Breast Cancer". The combination of paclitaxel, doxorubicin, and cyclophosphamide is a standard neoadjuvant (given before surgery) treatment for patients that have either inoperable or operable breast cancer. This treatment can help shrink the tumors so they can be removed to help prevent the cancer from spreading t...
What is the current status of trial NCT00656669?
This trial is currently completed. It is a NA study. The enrollment target is 23 participants. The study started on 2008-04. Estimated completion is 2010-09.
What interventions are being tested in trial NCT00656669?
The interventions under investigation include: sunitinib alone (DRUG), sunitinib plus paclitaxel (DRUG), doxorubicin and cyclophosphamide (DRUG).
Who is sponsoring clinical trial NCT00656669?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00656669's enrollment target sits among peer trials
23 1755th of 2000 higher than 245 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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