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NCT00769379 · ClinicalTrials.gov registry record · Phase 3
Radiation Therapy With or Without Trastuzumab in Treating Women With Ductal Carcinoma In Situ Who Have Undergone Lumpectomy
A Phase 3 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 3
- Development phase
- 2,014
- Enrollment target
NCT00769379: Completed Phase 3 study, sponsored by National Cancer Institute (NCI).
NCT00769379 is a Phase 3 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 2,014 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (161% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00769379, a Phase 3 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 2,014 participants
- Enrollment target
Study Summary
This randomized phase III trial studies radiation therapy to see how well it works with or without trastuzumab in treating women with ductal carcinoma in situ who have undergone lumpectomy. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether radiation therapy is more effective with or without trastuzumab in treating ductal carcinoma in situ.
Primary Outcome
Patients who are free from Ipsilateral Invasive Breast Cancer, Ipsilateral Skin Cancer Recurrence or Ipsilateral DCIS as estimated by (1- cumulative incidence) x 100%.
Interventions
- OTHER Laboratory Biomarker Analysis
- RADIATION Whole Breast Irradiation
- BIOLOGICAL Trastuzumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,014 participants |
| Start Date | 2008-12-10 |
| Est. Completion | 2025-06-02 |
| Phase | Phase 3 |
What the finished NCT00769379 record still lists
NCT00769379 is an interventional study that assigns participants to a tested intervention. Its 2,014 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (161% higher).
The record links to 0 conditions, and to 3 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT00769379 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00769379 about?
NCT00769379 is a clinical study titled "Radiation Therapy With or Without Trastuzumab in Treating Women With Ductal Carcinoma In Situ Who Have Undergone Lumpectomy". This randomized phase III trial studies radiation therapy to see how well it works with or without trastuzumab in treating women with ductal carcinoma in situ who have undergone lumpectomy. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability o...
What is the current status of trial NCT00769379?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 2,014 participants. The study started on 2008-12-10. Estimated completion is 2025-06-02.
What interventions are being tested in trial NCT00769379?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Whole Breast Irradiation (RADIATION), Trastuzumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT00769379?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00769379's enrollment target sits among peer trials
2,014 100th of 2000 higher than 1,901 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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