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Dose Dense Carboplatin, Taxotere and Herceptin As Primary Systemic Therapy in Breast Cancer

NCT00232479 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2012-08-21

Study results available
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Summary

Dose dense therapy has been shown to increase survival in the adjuvant setting of breast cancer. It is unknown if dose dense therapy will improve survival in tumors that express her-2. This study evaluates a neoadjuvant regimen containing carboplatin, taxotere and herceptin when used in a dose dense manner in patients with large breast cancers. The endpoint of pathologic complete response is used as a surrogate marker for survival.

Conditions

Interventions

DRUG

trastuzumab, docetaxel and carboplatin in dose dense regimen

trastuzumab 4 mg/kg day 1 and then 2 mg/kg/week x 11, carboplatin 6 mg AUC Day 1, 15, 29, 43, docetaxel 75 mg/meter squared Days 1, 15, 29, 43, neulasta 6 mg Day 2, 16, 30, 44

Sponsors & Collaborators

  • Aventis Pharmaceuticals

    collaborator INDUSTRY

  • University of Miami

    lead OTHER

Principal Investigators

  • Judith Hurley · University of Miami

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2008-05-31
Completion
2008-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT00232479 on ClinicalTrials.gov