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NCT00007904 · ClinicalTrials.gov registry record · Phase 2
Adjuvant Stage 2-3A Breast Cancer With Positive Lymph Nodes
A Phase 2 study of Breast Cancer, sponsored by Case Comprehensive Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
- 3
- Study locations
NCT00007904: Completed Phase 2 study of Breast Cancer, sponsored by Case Comprehensive Cancer Center.
NCT00007904 is a Phase 2 study of Breast Cancer that has completed, run by Case Comprehensive Cancer Center. The registered enrollment target is 16 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The trial reports 3 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00007904, a Phase 2 study of Breast Cancer, has completed, sponsored by Case Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
- 3
- Study locations
Study Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. Radiation therapy uses high-energy x-rays to damage tumor cells. PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with filgrastim and radiation therapy works in treating patients with stage II or stage IIIA breast cancer.
Primary Outcome
Paclitaxel 160 mg/m2 given over 72 hours by continuous infusion days 1-3 given concurrently with cyclophosphamide 700 mg/m2 daily for 3 day every 3 weeks cycles 1-3. Patients will be observed in the outpatient treatment area during the first 2 hours of the paclitaxel infusion for allergic reactions. Epinephrine, hydrocortisone, and IV antihistamine will be available.
Conditions Studied
Interventions
- DRUG cyclophosphamide
- DRUG paclitaxel
- BIOLOGICAL filgrastim
- DRUG doxorubicin hydrochloride
- DRUG tamoxifen citrate
Study Locations (3)
Ohio
- Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center - Cleveland
- UH-LUICC - Mentor
- UH-Chagrin Highlands - Orange
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2000-07 |
| Est. Completion | 2012-09 |
| Phase | Phase 2 |
What the finished NCT00007904 record still lists
NCT00007904 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which cyclophosphamide is the first listed.
NCT00007904 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT00007904 about?
NCT00007904 is a clinical study titled "Adjuvant Stage 2-3A Breast Cancer With Positive Lymph Nodes". RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from th...
What is the current status of trial NCT00007904?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2000-07. Estimated completion is 2012-09.
What conditions does trial NCT00007904 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT00007904?
The interventions under investigation include: cyclophosphamide (DRUG), paclitaxel (DRUG), filgrastim (BIOLOGICAL), doxorubicin hydrochloride (DRUG), tamoxifen citrate (DRUG).
Who is sponsoring clinical trial NCT00007904?
This trial is sponsored by Case Comprehensive Cancer Center, which has 407 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00007904 being conducted?
This trial has 3 study locations across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00007904's enrollment target sits among peer trials
16 1135th of 1224 higher than 82 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer 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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