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NCT00336791 · ClinicalTrials.gov registry record · Phase 3
Randomized Clinical Trial to Evaluate the Predictive Accuracy of a Gene Expression for Stage I-II Breast Cancer
A Phase 3 study of Breast Cancer, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 273
- Enrollment target
- 4
- Study locations
NCT00336791: Completed Phase 3 study of Breast Cancer, sponsored by M.D. Anderson Cancer Center.
NCT00336791 is a Phase 3 study of Breast Cancer that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 273 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (90% lower). The trial reports 4 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00336791, a Phase 3 study of Breast Cancer, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 273 participants
- Enrollment target
- 4
- Study locations
Study Summary
Primary Objectives: 1. To prospectively evaluate the predictive accuracy of a previously discovered gene expression profile-based test to foretell pathologic complete response (pCR) to preoperative paclitaxel/FAC (5-fluorouracil, doxorubicin, cyclophosphamide) chemotherapy for stage I-III breast cancer. 2. To evaluate if our genomic predictive test is specific to the paclitaxel/FAC regimen or it also predicts increased sensitivity to FAC only chemotherapy. Secondary Objectives: 1. To discover a molecular profile that is associated with pCR after FAC chemotherapy alone 2. To establish a prospectively collected gene expression profile data bank of breast cancer for future studies 3. To compare the pCR rates between patients who receive 6 courses FAC and those who receive sequential paclitaxel /FAC chemotherapies.
Primary Outcome
Pathologic Complete Response Rate after completion of preoperative chemotherapy, based on routine clinical pathology report where Pathologic complete response defined as complete absence of any viable invasive cancer cells in resected breast and lymph nodes. Specimens in breast may contain in situ cancer (ductal or lobular carcinoma in situ) and still be considered complete response.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Doxorubicin
- DRUG Paclitaxel
- DRUG 5-Fluorouracil
- DRUG Epirubicin
Study Locations (4)
Other
- Centro Medico Nacional de Occidente - Guadalajara
- Instituto Nacional de Enfermedades Neoplasicas - Lima
- Grupo Español de Investigacion en Cancer de Mama - Madrid
Texas
- UT MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 273 participants |
| Start Date | 2003-09 |
| Est. Completion | 2010-09 |
| Phase | Phase 3 |
What the finished NCT00336791 record still lists
NCT00336791 is an interventional study that assigns participants to a tested intervention. The registered 273 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (90% 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.
NCT00336791 reports a single indexed study location in Other, Texas.
Frequently Asked Questions
What is clinical trial NCT00336791 about?
NCT00336791 is a clinical study titled "Randomized Clinical Trial to Evaluate the Predictive Accuracy of a Gene Expression for Stage I-II Breast Cancer". Primary Objectives: 1. To prospectively evaluate the predictive accuracy of a previously discovered gene expression profile-based test to foretell pathologic complete response (pCR) to preoperative paclitaxel/FAC (5-fluorouracil, doxorubicin, cyclophosphamide) chemotherapy for stage I-III breast ca...
What is the current status of trial NCT00336791?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 273 participants. The study started on 2003-09. Estimated completion is 2010-09.
What conditions does trial NCT00336791 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT00336791?
The interventions under investigation include: Cyclophosphamide (DRUG), Doxorubicin (DRUG), Paclitaxel (DRUG), 5-Fluorouracil (DRUG), Epirubicin (DRUG).
Who is sponsoring clinical trial NCT00336791?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00336791 being conducted?
This trial has 4 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00336791's enrollment target sits among peer trials
273 303rd of 1224 higher than 922 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.
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