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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: Completed Phase 2 study, sponsored by University of Nebraska.
NCT00499083 is a Phase 2 study that has completed, run by University of Nebraska. The registered enrollment target is 17 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Assessed by the institutional pathologist. * Grade 1: disappearance of all tumor on microscopic assessment in the breast and LNs * Grade 2: presence of in situ carcinoma only in the breast, no invasive tumor, and no tumor found in the LNs * Grade 3: presence of invasive carcinoma with stromal alteration, such as sclerosis or fibrosis * Grade 4: no or few modifications of the tumor appearance
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 |
What the finished NCT00499083 record still lists
NCT00499083 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 5 interventions - of which cyclophosphamide is the first listed.
NCT00499083 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00499083's enrollment target sits among peer trials
17 1903rd of 2000 higher than 93 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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