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NCT00496808 · ClinicalTrials.gov registry record · NA

Neoadjuvant Herceptin for Ductal Carcinoma In Situ of the Breast

A NA study, sponsored by M.D. Anderson Cancer Center.

Completed
Registry status
NA
Development phase
69
Enrollment target

NCT00496808: Completed NA study, sponsored by M.D. Anderson Cancer Center.

NCT00496808 is a NA study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 69 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT00496808, a NA study, has completed, sponsored by M.D. Anderson Cancer Center.

COMPLETED
Registry status
NA
Development phase
69 participants
Enrollment target

Study Summary

Primary Objectives: * To determine the effect of a single dose of Herceptin (trastuzumab) on the proliferation rate of Her-2/neu over-expressing ductal carcinoma in situ (DCIS) * To evaluate the effect of a single dose of Herceptin on the apoptotic index of Her-2/neu over-expressing DCIS

Primary Outcome

Percent Change in Proliferation as measured by Ki-67 (% nuclei stained). Comparison of proliferation rates of Her-2/neu overexpressing cells before and after treatment with Herceptin per Participant where absolute change defined as difference of increase/decrease. Proliferation rate evaluated by immunohistochemistry using paraffin-embedded sections and monoclonal antibody for ki-67.

Interventions

  • DRUG Herceptin (Trastuzumab)

Trial Details

FieldValue
Enrollment Target 69 participants
Start Date 2005-03
Est. Completion 2010-11
Phase NA
M.D. Anderson Cancer Center

2,692 total trials

What the finished NCT00496808 record still lists

NCT00496808 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).

The record links to 0 conditions, and to 1 intervention - of which Herceptin (Trastuzumab) is the first listed.

NCT00496808 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00496808 about?

NCT00496808 is a clinical study titled "Neoadjuvant Herceptin for Ductal Carcinoma In Situ of the Breast". Primary Objectives: * To determine the effect of a single dose of Herceptin (trastuzumab) on the proliferation rate of Her-2/neu over-expressing ductal carcinoma in situ (DCIS) * To evaluate the effect of a single dose of Herceptin on the apoptotic index of Her-2/neu over-expressing DCIS

What is the current status of trial NCT00496808?

This trial is currently completed. It is a NA study. The enrollment target is 69 participants. The study started on 2005-03. Estimated completion is 2010-11.

What interventions are being tested in trial NCT00496808?

The interventions under investigation include: Herceptin (Trastuzumab) (DRUG).

Who is sponsoring clinical trial NCT00496808?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00496808's enrollment target sits among peer trials

69 1133rd of 2000 higher than 868 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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Source: ClinicalTrials.gov NCT00496808, the US trial registry maintained by the National Library of Medicine. NCT00496808 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.