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NCT01293032 · ClinicalTrials.gov registry record · NA
Hormone Therapy Or Chemotherapy Before Surgery Based on Gene Expression Analysis in Treating Patients With Breast Cancer
A NA study, sponsored by Virginia Commonwealth University.
- Completed
- Registry status
- NA
- Development phase
- 59
- Enrollment target
NCT01293032: Completed NA study, sponsored by Virginia Commonwealth University.
NCT01293032 is a NA study that has completed, run by Virginia Commonwealth University. The registered enrollment target is 59 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01293032, a NA study, has completed, sponsored by Virginia Commonwealth University.
- COMPLETED
- Registry status
- NA
- Development phase
- 59 participants
- Enrollment target
Study Summary
This randomized pilot clinical trial studied whether the Oncotype DX gene expression "Recurrence Score" (RS) would be useful for helping make a decision about which type of pre-operative treatment, hormone therapy or chemotherapy would be a better for patients with hormone responsive cancers that were not suitable for breast conserving surgery. The RS is currently used to predict the risk of distant recurrence and the benefit of the addition of chemotherapy to hormonal therapy in the adjuvant setting.
Primary Outcome
The primary purpose of this trial is to determine the feasibility of carrying out a large multi-center trial with a similar design. Feasibility, in terms of less than 1/3 of patients with intermediate (11-25) Recurrence Score (RS) who refused the assigned treatment (Group 2) or refused randomization between hormonal (Arm 1) or chemotherapy (Arm 2). The confidence interval will be 95%. The proportion (and 95% confidence interval) of patients with RS 11-25 who refuse the assigned treatment will be
Interventions
- OTHER Laboratory Biomarker Analysis
- PROCEDURE Therapeutic Conventional Surgery
- GENETIC Gene Expression Analysis
- PROCEDURE Neoadjuvant Therapy
- DRUG Systemic Chemotherapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2011-04 |
| Est. Completion | 2016-03 |
| Phase | NA |
What the finished NCT01293032 record still lists
NCT01293032 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 5 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT01293032 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01293032 about?
NCT01293032 is a clinical study titled "Hormone Therapy Or Chemotherapy Before Surgery Based on Gene Expression Analysis in Treating Patients With Breast Cancer". This randomized pilot clinical trial studied whether the Oncotype DX gene expression "Recurrence Score" (RS) would be useful for helping make a decision about which type of pre-operative treatment, hormone therapy or chemotherapy would be a better for patients with hormone responsive cancers that we...
What is the current status of trial NCT01293032?
This trial is currently completed. It is a NA study. The enrollment target is 59 participants. The study started on 2011-04. Estimated completion is 2016-03.
What interventions are being tested in trial NCT01293032?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Therapeutic Conventional Surgery (PROCEDURE), Gene Expression Analysis (GENETIC), Neoadjuvant Therapy (PROCEDURE), Systemic Chemotherapy (DRUG).
Who is sponsoring clinical trial NCT01293032?
This trial is sponsored by Virginia Commonwealth University, which has 558 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01293032's enrollment target sits among peer trials
59 1256th of 2000 higher than 745 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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