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NCT01827163 · ClinicalTrials.gov registry record · Phase 2

Paclitaxel With Trastuzumab and Lapatinib in HER2-Positive Early Stage Breast Cancer

A Phase 2 study, sponsored by Memorial Sloan Kettering Cancer Center.

Completed
Registry status
Phase 2
Development phase
20
Enrollment target

NCT01827163: Completed Phase 2 study, sponsored by Memorial Sloan Kettering Cancer Center.

NCT01827163 is a Phase 2 study that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

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The verdict

NCT01827163, a Phase 2 study, has completed, sponsored by Memorial Sloan Kettering Cancer Center.

COMPLETED
Registry status
Phase 2
Development phase
20 participants
Enrollment target

Study Summary

The purpose of this study is to study a new treatment for HER2-positive breast cancer.

Primary Outcome

The primary objective of this trial is to determine the feasibility of this regimen in patients with node-negative HER-2/neu overexpressed /amplified breast cancer with a tumor size of \< 3 cm. The regimen is considered feasible if patients are able to complete the paclitaxel, trastuzumab, and lapatinib (THL) portion of the regimen without a dose delay or reduction or grade 3 or greater QTc prolongation.

Interventions

  • DRUG Trastuzumab
  • DRUG Paclitaxel
  • DRUG Pegfilgrastim
  • DRUG Lapatinib

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2013-04
Est. Completion 2019-01
Phase Phase 2
Memorial Sloan Kettering Cancer Center

1,884 total trials

What the finished NCT01827163 record still lists

NCT01827163 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).

The record links to 0 conditions, and to 4 interventions - of which Trastuzumab is the first listed.

NCT01827163 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01827163 about?

NCT01827163 is a clinical study titled "Paclitaxel With Trastuzumab and Lapatinib in HER2-Positive Early Stage Breast Cancer". The purpose of this study is to study a new treatment for HER2-positive breast cancer.

What is the current status of trial NCT01827163?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2013-04. Estimated completion is 2019-01.

What interventions are being tested in trial NCT01827163?

The interventions under investigation include: Trastuzumab (DRUG), Paclitaxel (DRUG), Pegfilgrastim (DRUG), Lapatinib (DRUG).

Who is sponsoring clinical trial NCT01827163?

This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01827163's enrollment target sits among peer trials

20 1805th of 2000 higher than 107 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT01827163, the US trial registry maintained by the National Library of Medicine. NCT01827163 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.