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Preoperative Chemotherapy With Paclitaxel, Gemcitabine, and Lapatinib (Tykerb®) (PGT)

NCT01133912 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2012-01-04

No results posted yet for this study

Summary

Primary objectives :

1\. To evaluate the recommended dose of the combination of paclitaxel, gemcitabine, and lapatinib (Tykerb®) (PGT) as preoperative chemotherapy in patients with HER2 positive operable breast cancer

Secondary objectives :

1. To evaluate the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of PGT
2. To determine the safety profile
3. To assess pCR in primary tumor and axillary LN
4. To evaluate clinical response rate, disease free survival (DFS), and overall survival (OS)
5. To assess breast conserving rate after preoperative PGT

Conditions

Interventions

DRUG

paclitaxel, gemcitabine, lapatinib

Patients receive paclitaxel and gemcitabine intravenously (iv) on day 1 and 8, and oral lapatinib once daily. Lapatinib with fixed dose will be given once a day p.o. from day 1 without resting during each cycle. The starting doses of paclitaxel 80mg/m2 and gemcitabine 1000mg/m2 iv, on day 1 and 8, and lapatinib 1000mg p.o., daily (dose level 1) will be administered every 21 days.

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • HK inno.N Corporation

    collaborator INDUSTRY

  • Jungsil Ro

    lead OTHER_GOV

Principal Investigators

  • Jungsil Ro, MD · National Cencer Center, Korea

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2010-06-30
Completion
2011-10-31

Countries

  • South Korea

Study Locations

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Entities

Diseases
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 NCT01133912 on ClinicalTrials.gov