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Combination Chemotherapy With or Without Darbepoetin Alfa in Treating Women With Stage III Breast Cancer

NCT00309920 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1234

Last updated 2009-02-09

No results posted yet for this study

Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Colony-stimulating factors, such as darbepoetin alfa, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy. Giving combination chemotherapy together with darbepoetin alfa after surgery may kill any tumor cells that remain after surgery. It is not yet known whether combination chemotherapy and darbepoetin alfa are more effective than combination chemotherapy alone in treating stage III breast cancer.

PURPOSE: This randomized clinical trial is studying how well giving combination chemotherapy together with darbepoetin alfa works compared to combination chemotherapy alone in treating women with stage III breast cancer.

Conditions

Interventions

BIOLOGICAL

darbepoetin alfa

DRUG

cyclophosphamide

DRUG

docetaxel

DRUG

doxorubicin hydrochloride

DRUG

epirubicin hydrochloride

DRUG

fluorouracil

Sponsors & Collaborators

  • Heinrich-Heine University, Duesseldorf

    lead OTHER

Principal Investigators

  • Ulrike Nitz, PhD · Heinrich-Heine University, Duesseldorf

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-01-31

Countries

  • Germany

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 NCT00309920 on ClinicalTrials.gov