MedTrace Logo

Combination Chemotherapy With or Without Trastuzumab in Treating Women With Metastatic Breast Cancer

NCT00004888 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2014-05-23

Study results available
· View outcomes & findings →

Summary

Phase II trial to study the effectiveness of combination chemotherapy with or without trastuzumab in treating women who have metastatic breast cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

Conditions

  • Recurrent Breast Cancer
  • Stage IV Breast Cancer

Interventions

DRUG

pegylated liposomal doxorubicin hydrochloride

Given IV

DRUG

docetaxel

Given IV

BIOLOGICAL

trastuzumab

Given IV

OTHER

laboratory biomarker analysis

Correlative studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Antonio Wolff · Eastern Cooperative Oncology Group

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-01-31
Primary Completion
2008-04-30
Completion
2009-05-31

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 NCT00004888 on ClinicalTrials.gov