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NCT01479101 · ClinicalTrials.gov registry record
NBRST: Prospective Neo-adjuvant REGISTRY Trial
A clinical trial, sponsored by Agendia.
- Completed
- Registry status
- 1,142
- Enrollment target
NCT01479101: Completed study, sponsored by Agendia.
NCT01479101 is a clinical trial that has completed, run by Agendia. The registered enrollment target is 1,142 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01479101 has completed, sponsored by Agendia.
- COMPLETED
- Registry status
- 1,142 participants
- Enrollment target
Study Summary
The scope of this registry study is to measure chemosensitivity as defined by pCR (primary endpoint), or endocrine sensitivity as defined by partial response (decrease in longest tumor diameter or residual cancer burden category 1 (RCB1), a primary endpoint for neo-adjuvant endocrine therapy and a secondary endpoint for neoadjuvant chemotherapy), metastasis-free survival and relapse-free survival(secondary endpoints) in molecular subgroups, determined by the established MammaPrint, BluePrint, Targetprint and Theraprint profiles in addition to possible novel expression profiles.
Primary Outcome
For neo-adjuvant chemotherapy patients the primary endpoint is pathological complete response (pCR) which is defined as the absence of invasive carcinoma in both the breast and axilla at microscopic examination of the resection specimen, regardless of the presence of carcinoma in situ. The response rate and corresponding confidence intervals will be presented as a proportion of all patients enrolled. Comparison of response rates between different molecular subgroups will be conducted using Pears
Interventions
- OTHER MammaPrint 70-gene expression profile
- OTHER BluePrint 80 gene expression profile
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,142 participants |
| Start Date | 2011-07 |
| Est. Completion | 2021-01 |
What the finished NCT01479101 record still lists
NCT01479101 is an observational study that tracks outcomes without assigning an intervention. Its 1,142 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 2 interventions - of which MammaPrint 70-gene expression profile is the first listed.
NCT01479101 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01479101 about?
NCT01479101 is a clinical study titled "NBRST: Prospective Neo-adjuvant REGISTRY Trial". The scope of this registry study is to measure chemosensitivity as defined by pCR (primary endpoint), or endocrine sensitivity as defined by partial response (decrease in longest tumor diameter or residual cancer burden category 1 (RCB1), a primary endpoint for neo-adjuvant endocrine therapy and a s...
What is the current status of trial NCT01479101?
This trial is currently completed. The enrollment target is 1,142 participants. The study started on 2011-07. Estimated completion is 2021-01.
What interventions are being tested in trial NCT01479101?
The interventions under investigation include: MammaPrint 70-gene expression profile (OTHER), BluePrint 80 gene expression profile (OTHER).
Who is sponsoring clinical trial NCT01479101?
This trial is sponsored by Agendia, which has 6 total clinical trials registered on ClinicalTrials.gov.
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