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NCT00304096 · ClinicalTrials.gov registry record · Phase 1

Vaccine Therapy in Treating Patients With Stage III or Stage IV Breast Cancer

A Phase 1 study, sponsored by University of Virginia.

Completed
Registry status
Phase 1
Development phase
12
Enrollment target

NCT00304096: Completed Phase 1 study, sponsored by University of Virginia.

NCT00304096 is a Phase 1 study that has completed, run by University of Virginia. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00304096, a Phase 1 study, has completed, sponsored by University of Virginia.

COMPLETED
Registry status
Phase 1
Development phase
12 participants
Enrollment target

Study Summary

RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Giving booster vaccinations may make a stronger immune response and kill more tumor cells. PURPOSE: This phase I trial is studying the side effects of vaccine therapy in treating patients with stage III or stage IV breast cancer.

Primary Outcome

Safety of the 9-peptide mixture if fewer than 33% of patients experience a dose-limiting toxicity

Interventions

  • BIOLOGICAL synthetic breast cancer peptides-tetanus toxoid-Montanide ISA-51 vaccine

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2005-12
Est. Completion 2008-04
Phase Phase 1
University of Virginia

449 total trials

What the finished NCT00304096 record still lists

NCT00304096 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).

The record links to 0 conditions, and to 1 intervention - of which synthetic breast cancer peptides-tetanus toxoid-Montanide ISA-51 vaccine is the first listed.

NCT00304096 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00304096 about?

NCT00304096 is a clinical study titled "Vaccine Therapy in Treating Patients With Stage III or Stage IV Breast Cancer". RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells. Giving booster vaccinations may make a stronger immune response and kill more tumor cells. PURPOSE: This phase I trial is studying the side effects of vaccine therapy in treating patient...

What is the current status of trial NCT00304096?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2005-12. Estimated completion is 2008-04.

What interventions are being tested in trial NCT00304096?

The interventions under investigation include: synthetic breast cancer peptides-tetanus toxoid-Montanide ISA-51 vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT00304096?

This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00304096's enrollment target sits among peer trials

12 1852nd of 2000 higher than 90 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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 NCT00304096, the US trial registry maintained by the National Library of Medicine. NCT00304096 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.