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NCT01816035 · ClinicalTrials.gov registry record · Phase 1

Trastuzumab Emtansine in Treating Patients With HER2-Positive Metastatic or Locally Advanced Breast Cancer That Cannot Be Removed by Surgery

A Phase 1 study, sponsored by University of Washington.

Completed
Registry status
Phase 1
Development phase
13
Enrollment target

NCT01816035: Completed Phase 1 study, sponsored by University of Washington.

NCT01816035 is a Phase 1 study that has completed, run by University of Washington. The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01816035, a Phase 1 study, has completed, sponsored by University of Washington.

COMPLETED
Registry status
Phase 1
Development phase
13 participants
Enrollment target

Study Summary

This phase I trial studies the side effects and best way of giving trastuzumab emtansine in treating patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer that has spread to other parts of the body or nearby tissue and cannot be removed by surgery. Biological therapies, such as trastuzumab emtansine, may stimulate the immune system in different ways and stop cancer cells from growing.

Interventions

  • OTHER Laboratory Biomarker Analysis
  • OTHER Pharmacological Study
  • BIOLOGICAL Trastuzumab Emtansine

Trial Details

FieldValue
Enrollment Target 13 participants
Start Date 2014-06
Est. Completion 2017-04
Phase Phase 1
University of Washington

1,048 total trials

What the finished NCT01816035 record still lists

NCT01816035 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).

The record links to 0 conditions, and to 3 interventions - of which Laboratory Biomarker Analysis is the first listed.

NCT01816035 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01816035 about?

NCT01816035 is a clinical study titled "Trastuzumab Emtansine in Treating Patients With HER2-Positive Metastatic or Locally Advanced Breast Cancer That Cannot Be Removed by Surgery". This phase I trial studies the side effects and best way of giving trastuzumab emtansine in treating patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer that has spread to other parts of the body or nearby tissue and cannot be removed by surgery. Biological therapies...

What is the current status of trial NCT01816035?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2014-06. Estimated completion is 2017-04.

What interventions are being tested in trial NCT01816035?

The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Pharmacological Study (OTHER), Trastuzumab Emtansine (BIOLOGICAL).

Who is sponsoring clinical trial NCT01816035?

This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01816035's enrollment target sits among peer trials

13 1847th of 2000 higher than 149 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 NCT01816035, the US trial registry maintained by the National Library of Medicine. NCT01816035 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.