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NCT00254592 · ClinicalTrials.gov registry record · Phase 2
Neoadjuvant Treatment of Breast Cancer
A Phase 2 study, sponsored by University of California, Irvine.
- Completed
- Registry status
- Phase 2
- Development phase
- 43
- Enrollment target
NCT00254592 is a Phase 2 study that has completed, run by University of California, Irvine. The registered enrollment target is 43 participants.
The verdict
NCT00254592, a Phase 2 study, has completed, sponsored by University of California, Irvine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 43 participants
- Enrollment target
Study Summary
Study Aims 1. To measure the clinic response rates in patients with breast cancer more than 2 cm and/or lymph node positive breast cancer treated with 2-4 cycles of biweekly doxorubicin, cyclophosphamide with Granulocyte-macrophage colony-stimulating factor (GM-CSF) (days 4-13) followed by weekly carboplatin/nab-paclitaxel given for 3 weeks, followed by 1 week of rest, for a total of 9-12 doses. (Her-2 positive patients, in addition, will receive Trastuzumab weekly (12-16 doses) and Her-2 negative patients will receive Bevacizumab (6-8 doses) q 2 weeks). 2. To measure the microscopic pathological response rate of this regimen. 3. To measure toxicity and the delivered dose intensity of this regimen. 4. To assess the association between microscopic pathologic complete response and clinical complete response at the primary tumor site in these patients. 5. To determine whether the GM-CSF increases the post treatment dendritic cells (S100+) percentage in the tumor draining lymph node as compared to pretreatment S100+ cells. 6. To determine whether the patients with a higher percent S100+ have a better clinical, pathological response, Disease Free Survival (DFS), and overall Survival (OS). 7. To determine whether flow cytometry of dendritic cells performed post-treatment in blood sample shows an increase in dendritic cell population compared to pretreatment levels.
Interventions
- DRUG Cyclophosphamide
- DRUG Carboplatin
- DRUG Doxorubicin
- DRUG Nab-paclitaxel
- DRUG GM-CSF
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2005-10 |
| Est. Completion | 2013-09-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00254592
The ClinicalTrials.gov registry entry for NCT00254592 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Irvine, which has 368 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT00254592 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00254592 about?
NCT00254592 is a clinical study titled "Neoadjuvant Treatment of Breast Cancer". Study Aims 1. To measure the clinic response rates in patients with breast cancer more than 2 cm and/or lymph node positive breast cancer treated with 2-4 cycles of biweekly doxorubicin, cyclophosphamide with Granulocyte-macrophage colony-stimulating factor (GM-CSF) (days 4-13) followed by weekly c...
What is the current status of trial NCT00254592?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 43 participants. The study started on 2005-10. Estimated completion is 2013-09-04.
What interventions are being tested in trial NCT00254592?
The interventions under investigation include: Cyclophosphamide (DRUG), Carboplatin (DRUG), Doxorubicin (DRUG), Nab-paclitaxel (DRUG), GM-CSF (DRUG).
Who is sponsoring clinical trial NCT00254592?
This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.
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