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

NCT01827163 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-12-18

Study results available
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Summary

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

Conditions

  • HER2-Positive Early Stage Breast Cancer

Interventions

DRUG

Paclitaxel

DRUG

Trastuzumab

The q 3 week trastuzumab may be started at the last dose of paclitaxel infusion or from 1-3 weeks after the last dose of paclitaxel. Trastuzumab may also be administered at a dose of 6mg/kg during the last dose of paclitaxel in the THL phase.

DRUG

Lapatinib

DRUG

Pegfilgrastim

Pegfilgrastim SQ is given on day # 2 of each paclitaxel cycle and may be dropped at the last paclitaxel infusion. Filgrastim may be used in lieu of pegfilgrastim at the physician's discretion.

Sponsors & Collaborators

Principal Investigators

  • Chau Dang, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2019-01-31
Completion
2019-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01827163 on ClinicalTrials.gov