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NCT00499083 · ClinicalTrials.gov registry record · Phase 2
Paclitaxel, Cyclophosphamide & Doxorubicin, Autologous Dendritic Cells & Surgery in Stage II/III Breast Cancer (Women)
A Phase 2 study, sponsored by University of Nebraska.
- Completed
- Registry status
- Phase 2
- Development phase
- 17
- Enrollment target
NCT00499083 is a Phase 2 study that has completed, run by University of Nebraska. The registered enrollment target is 17 participants.
The verdict
NCT00499083, a Phase 2 study, has completed, sponsored by University of Nebraska.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 17 participants
- Enrollment target
Study Summary
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, cyclophosphamide, and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Injecting the patient's dendritic cells directly into the tumor may stimulate the immune system and stop tumor cells from growing. Radiation therapy uses high-energy x-rays to kill tumor cells. Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the use of estrogen by the tumor cells. Giving combination chemotherapy together with autologous dendritic cells before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving radiation therapy and hormone therapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying the side effects and how well giving paclitaxel together with cyclophosphamide and doxorubicin followed by autologous dendritic cells and surgery with or without radiation therapy and/or hormone therapy works in treating women with stage II or stage III breast cancer.
Interventions
- DRUG cyclophosphamide
- DRUG paclitaxel
- DRUG doxorubicin hydrochloride
- DRUG aromatase inhibition therapy
- BIOLOGICAL therapeutic autologous dendritic cells
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2006-05-01 |
| Est. Completion | 2010-01-28 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00499083
The ClinicalTrials.gov registry entry for NCT00499083 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Nebraska, which has 407 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which cyclophosphamide is the first listed.
NCT00499083 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00499083 about?
NCT00499083 is a clinical study titled "Paclitaxel, Cyclophosphamide & Doxorubicin, Autologous Dendritic Cells & Surgery in Stage II/III Breast Cancer (Women)". RATIONALE: Drugs used in chemotherapy, such as paclitaxel, cyclophosphamide, and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Injecting the patient's dendritic cells directly into the tumor may stimulate the imm...
What is the current status of trial NCT00499083?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2006-05-01. Estimated completion is 2010-01-28.
What interventions are being tested in trial NCT00499083?
The interventions under investigation include: cyclophosphamide (DRUG), paclitaxel (DRUG), doxorubicin hydrochloride (DRUG), aromatase inhibition therapy (DRUG), therapeutic autologous dendritic cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT00499083?
This trial is sponsored by University of Nebraska, which has 407 total clinical trials registered on ClinicalTrials.gov.
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