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NCT01048099 · ClinicalTrials.gov registry record · NA
Use of PRO Onc Assay to Assess HER2 in Patients With Metastatic Breast Cancer
A NA study, sponsored by SCRI Development Innovations.
- Completed
- Registry status
- NA
- Development phase
- 283
- Enrollment target
NCT01048099: Completed NA study, sponsored by SCRI Development Innovations.
NCT01048099 is a NA study that has completed, run by SCRI Development Innovations. The registered enrollment target is 283 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01048099, a NA study, has completed, sponsored by SCRI Development Innovations.
- COMPLETED
- Registry status
- NA
- Development phase
- 283 participants
- Enrollment target
Study Summary
This trial will evaluate the clinical significance of the PRO Onc assay and will assess the efficacy of HER2-targeted therapy in patients with HER2-negative breast cancer who have been identified as having HER2 overexpression/activation by the PRO Onc Assay.
Primary Outcome
The percentage of HER2-negative metastatic breast cancer (MBC) patients having an objective benefit from treatment per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: 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. Includes patients with HER2 overexpression/activation as detected by PRO Onc Ass
Interventions
- DRUG Trastuzumab
- DRUG Pertuzumab
- PROCEDURE PRO Onc Assay and Treatment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 283 participants |
| Start Date | 2011-01 |
| Est. Completion | 2014-07 |
| Phase | NA |
What the finished NCT01048099 record still lists
NCT01048099 is an interventional study that assigns participants to a tested intervention. The registered 283 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 3 interventions - of which Trastuzumab is the first listed.
NCT01048099 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01048099 about?
NCT01048099 is a clinical study titled "Use of PRO Onc Assay to Assess HER2 in Patients With Metastatic Breast Cancer". This trial will evaluate the clinical significance of the PRO Onc assay and will assess the efficacy of HER2-targeted therapy in patients with HER2-negative breast cancer who have been identified as having HER2 overexpression/activation by the PRO Onc Assay.
What is the current status of trial NCT01048099?
This trial is currently completed. It is a NA study. The enrollment target is 283 participants. The study started on 2011-01. Estimated completion is 2014-07.
What interventions are being tested in trial NCT01048099?
The interventions under investigation include: Trastuzumab (DRUG), Pertuzumab (DRUG), PRO Onc Assay and Treatment (PROCEDURE).
Who is sponsoring clinical trial NCT01048099?
This trial is sponsored by SCRI Development Innovations, which has 146 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01048099's enrollment target sits among peer trials
283 378th of 2000 higher than 1,622 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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