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NCT01869192 · ClinicalTrials.gov registry record · Phase 2
Phase II Trial for Large ER-Negative Breast Cancers
A Phase 2 study of Malignant Neoplasm of Female Breast, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- Phase 2
- Development phase
- 72
- Enrollment target
- 1
- Study location
NCT01869192: Completed Phase 2 study of Malignant Neoplasm of Female Breast, sponsored by University of Colorado, Denver.
NCT01869192 is a Phase 2 study of Malignant Neoplasm of Female Breast that has completed, run by University of Colorado, Denver. The registered enrollment target is 72 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (46% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01869192, a Phase 2 study of Malignant Neoplasm of Female Breast, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 72 participants
- Enrollment target
- 1
- Study location
Study Summary
A primary objective of this study is to evaluate the in vivo response of tumor to chemotherapy through gene microarray analysis. Neoadjuvant treatment allows the unique opportunity to observe the in vivo effects of cytotoxic therapy on gene expression in tumor tissue. The investigators plan to evaluate several different questions by comparing gene profiles in different phases of treatment in this study. These are outlined below. Hypotheses 1. Chemotherapy enriches for tumor cell populations that have enhanced resistance and survival mechanisms. These mechanisms will in part be identifiable through changes in gene expression profiles pre vs. post treatment. 2. Use of two distinct chemotherapy selection pressures, for example a DNA-damaging regimen (epirubicin and cyclophosphamide) or a mitotic spindle/metabolic targeted regimen (docetaxel and capecitabine), will allow for the identification of a smaller set of genes associated to resistance and survival mechanisms of broad importance. 3. Genes associated with enrichment for resistance and survival mechanisms will not be present in large amounts pretreatment in tumors destined for complete pathologic response.
Primary Outcome
To describe the overall response rate as measured by physical exam and MRI if indicated using the following definition: Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Docetaxel
- DRUG Capecitabine
- RADIATION Radiation Therapy
- DRUG Epirubicin
Study Locations (1)
Colorado
- University of Colorado Cancer Center - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2003-03-05 |
| Est. Completion | 2010-08-21 |
| Phase | Phase 2 |
What the finished NCT01869192 record still lists
NCT01869192 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (46% lower).
The record links to 1 condition, with Malignant Neoplasm of Female Breast appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT01869192 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT01869192 about?
NCT01869192 is a clinical study titled "Phase II Trial for Large ER-Negative Breast Cancers". A primary objective of this study is to evaluate the in vivo response of tumor to chemotherapy through gene microarray analysis. Neoadjuvant treatment allows the unique opportunity to observe the in vivo effects of cytotoxic therapy on gene expression in tumor tissue. The investigators plan to evalu...
What is the current status of trial NCT01869192?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 72 participants. The study started on 2003-03-05. Estimated completion is 2010-08-21.
What conditions does trial NCT01869192 study?
This clinical trial studies the following conditions: Malignant Neoplasm of Female Breast.
What interventions are being tested in trial NCT01869192?
The interventions under investigation include: Cyclophosphamide (DRUG), Docetaxel (DRUG), Capecitabine (DRUG), Radiation Therapy (RADIATION), Epirubicin (DRUG).
Who is sponsoring clinical trial NCT01869192?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01869192 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01869192's enrollment target sits among peer trials
72 925th of 2000 higher than 1,065 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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