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NCT01208974 · ClinicalTrials.gov registry record · NA
Nipple-Areola Complex (NAC) Irradiation After Nipple-Sparing Mastectomy and Reconstruction
A NA study of Breast Cancer and Ductal Carcinoma, sponsored by University of Miami.
- Active
- Registry status
- NA
- Development phase
- 21
- Enrollment target
- 1
- Study location
NCT01208974: Active NA study of Breast Cancer and Ductal Carcinoma, sponsored by University of Miami.
NCT01208974 is a NA study of Breast Cancer and Ductal Carcinoma that is active but no longer recruiting, run by University of Miami. The registered enrollment target is 21 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01208974, a NA study of Breast Cancer and Ductal Carcinoma, is active but no longer recruiting, sponsored by University of Miami.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 21 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this research study is to see if a participant's nipple and areola can be safely preserved by adding radiation to these areas after a nipple-sparing mastectomy and immediate breast reconstruction.
Primary Outcome
The recommended Phase II dose will be reported as the MTD at which only 0 or 1 out of 6 participants experiences dose limiting toxicity (DLT). DLT will be reported as any of the following: Grade 4 skin rash or pain, NAC necrosis, any toxicity requiring interruption of NAC irradiation greater than 2 weeks or any grade 4 or 5 treatment related toxicity. Toxicity will be evaluated by treating physician using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) ve
Conditions Studied
Interventions
- PROCEDURE Nipple-Sparing Mastectomy
- PROCEDURE Breast Reconstruction
- PROCEDURE Axillary Surgery
- RADIATION Prophylactic Nipple-Areolar Complex RT
Study Locations (1)
Florida
- University of Miami Sylvester Comprehensive Cancer Center - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2010-03-16 |
| Est. Completion | 2026-05-31 |
| Phase | NA |
What the registry record for NCT01208974 still lists
NCT01208974 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower).
The record links to 2 conditions, with Breast Cancer appearing as the primary indexed condition, and to 4 interventions - of which Nipple-Sparing Mastectomy is the first listed.
NCT01208974 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT01208974 about?
NCT01208974 is a clinical study titled "Nipple-Areola Complex (NAC) Irradiation After Nipple-Sparing Mastectomy and Reconstruction". The purpose of this research study is to see if a participant's nipple and areola can be safely preserved by adding radiation to these areas after a nipple-sparing mastectomy and immediate breast reconstruction.
What is the current status of trial NCT01208974?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 21 participants. The study started on 2010-03-16. Estimated completion is 2026-05-31.
What conditions does trial NCT01208974 study?
This clinical trial studies the following conditions: Breast Cancer, Ductal Carcinoma.
What interventions are being tested in trial NCT01208974?
The interventions under investigation include: Nipple-Sparing Mastectomy (PROCEDURE), Breast Reconstruction (PROCEDURE), Axillary Surgery (PROCEDURE), Prophylactic Nipple-Areolar Complex RT (RADIATION).
Who is sponsoring clinical trial NCT01208974?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01208974 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01208974's enrollment target sits among peer trials
21 1073rd of 1224 higher than 147 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer 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.
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