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Phase II Neoadjuvant Trial of Trastuzumab in Combination With Dose-Dense ABI-007 (Abraxane™)

NCT00503750 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2012-06-25

Study results available
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Summary

This is a phase II one arm study. Patients with HER2 (Human Epidermal Growth Factor Receptor 2)positive early stage breast cancer will receive ABI-007 and vinorelbine in combination with trastuzumab before having breast surgery.

Conditions

Interventions

DRUG

Pre operativeTrastuzumab

Trastuzumab one-time loading dose of 4 mg/kg as 90 minute infusion, followed by 20 weekly treatments at 2 mg/kg as 30 minute infusion. As per standard treatment of HER2-positive breast cancers, patients will continue to receive trastuzumab every 3 weeks at 6 mg/kg beginning week 21 through week 52.

DRUG

ABI-007 (Abraxane)

ABI-007 will be administered every 2 weeks at a dose of 260mg/m2 as 30 minute infusion on the same days as trastuzumab for a total of 4 cycles (weeks 1 -8).

DRUG

Vinorelbine

Beginning week 9, patients will then receive weekly vinorelbine at a dose of 25mg/m2 for 12 weeks on the same day as trastuzumab for a total of 4 cycles (weeks 9-20).

Sponsors & Collaborators

  • Emory University

    lead OTHER

Principal Investigators

  • Ruth O'Regan, MD · Emory University Winship Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT00503750 on ClinicalTrials.gov