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Neoadjuvant Chemotherapy + Herceptin in HER2 Positive Stage II-III Breast Cancer Patients

NCT00270894 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2012-03-20

Study results available
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Summary

The purpose of this study is to evaluate the effectiveness and tolerability of the combination of the following medications given every two weeks in HER2 positive breast cancer patients:

* trastuzumab (Herceptin)
* epirubicin (Ellence)
* cyclophosphamide (Cytoxan)
* docetaxel (Taxotere)

Conditions

  • Breast Neoplasm

Interventions

DRUG

epirubicin

epirubicin (100 mg/m\^2) every 2 weeks for 4 cycles

DRUG

cyclophosphamide

cyclophosphamide (600 mg/m\^2) every 2 weeks for 4 cycles

DRUG

docetaxel

docetaxel (75 mg/m\^2) every 2 weeks for 4 cycles

DRUG

trastuzumab

trastuzumab (6 mg/kg \[loading dose\] once then 4 mg/kg \[maintenance dose\]) every 2 weeks for 4 treatments

Sponsors & Collaborators

  • Aventis Pharmaceuticals

    collaborator INDUSTRY

  • Accelerated Community Oncology Research Network

    lead OTHER

Principal Investigators

  • Lee S Schwartzberg, MD, FACP · Accelerated Community Oncology Research Network, Inc. (ACORN)

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2011-08-31
Completion
2011-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00270894 on ClinicalTrials.gov