Phase II Study of Primary Chemotherapy With Paclitaxel, Gemcitabine, and Trastuzumab

NCT00532857 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2012-01-04

No results posted yet for this study

Summary

To evaluate the pathologic complete response rate to preoperative administration of Paclitaxel, Gemcitabine, and Trastuzumab (HerceptinÒ) (PGH)

Conditions

Interventions

DRUG

Paclitaxel/Gemcitabine/Trastuzumab

80 mg/m2 of paclitaxel 1,200 mg/m2 of gemcitabine, day 1, day 8 every 3-week. trastuzumab at a dose of 4 mg/kg IV on D1 of first treatment cycle subsequently given weekly at a dose of 2 mg/kg

Sponsors & Collaborators

  • Jungsil Ro

    lead OTHER_GOV

Principal Investigators

  • Jungsil Ro, MD,PhD · National Cancer Center, Korea

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2008-02-29
Completion
2011-09-30

Countries

  • South Korea

Study Locations

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Entities

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 NCT00532857 on ClinicalTrials.gov