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NCT00499122 · ClinicalTrials.gov registry record · Phase 2
NOV-002, Doxorubicin, Cyclophosphamide, and Docetaxel in Women With Newly Diagnosed Stage II or IIIC Breast Cancer
A Phase 2 study, sponsored by University of Miami.
- Completed
- Registry status
- Phase 2
- Development phase
- 41
- Enrollment target
NCT00499122: Completed Phase 2 study, sponsored by University of Miami.
NCT00499122 is a Phase 2 study that has completed, run by University of Miami. The registered enrollment target is 41 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00499122, a Phase 2 study, has completed, sponsored by University of Miami.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 41 participants
- Enrollment target
Study Summary
RATIONALE: Oxidized glutathione (NOV-002) may stimulate the immune system in different ways and stop tumor cells from growing. Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving NOV-002 together with chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase II trial is studying how well giving oxidized glutathione (NOV-002) together with doxorubicin and cyclophosphamide followed by docetaxel works in treating women with newly diagnosed stage II or stage III breast cancer.
Primary Outcome
The primary objective of this study is to define the rate of pathologic complete response rate (pCR) in the affected breast after the preoperative administration of NOV-002 in combination with doxorubicin and cyclophosphamide followed by docetaxel in patients with stage IIB-IIIC breast cancer. Pathologic complete response (pCR) is defined according to Hankoop et al \[41\] as either: the absence of any histological evidence of invasive breast cancer cells in the tissue specimen removed from the b
Interventions
- DRUG Cyclophosphamide
- DRUG Docetaxel
- DRUG Doxorubicin
- DRUG NOV 002
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 41 participants |
| Start Date | 2007-06-04 |
| Est. Completion | 2011-04 |
| Phase | Phase 2 |
What the finished NCT00499122 record still lists
NCT00499122 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 41 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (69% lower).
The record links to 0 conditions, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT00499122 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00499122 about?
NCT00499122 is a clinical study titled "NOV-002, Doxorubicin, Cyclophosphamide, and Docetaxel in Women With Newly Diagnosed Stage II or IIIC Breast Cancer". RATIONALE: Oxidized glutathione (NOV-002) may stimulate the immune system in different ways and stop tumor cells from growing. Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by...
What is the current status of trial NCT00499122?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 41 participants. The study started on 2007-06-04. Estimated completion is 2011-04.
What interventions are being tested in trial NCT00499122?
The interventions under investigation include: Cyclophosphamide (DRUG), Docetaxel (DRUG), Doxorubicin (DRUG), NOV 002 (DRUG).
Who is sponsoring clinical trial NCT00499122?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00499122's enrollment target sits among peer trials
41 1352nd of 2000 higher than 639 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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