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Randomized Phase III Trial Comparing Sequential Administration of FE75C Followed by Docetaxel Versus Paclitaxel as Adjuvant Chemotherapy in Axillary Lymph Node (+) Breast Cancer

NCT00431080 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 478

Last updated 2008-01-21

No results posted yet for this study

Summary

Anthracycline-containing regimens are recommended as adjuvant treatment for women with node positive breast cancer. In at least three large randomized clinical trials the addition or sequential administration of a taxane (paclitaxel or docetaxel) to an antracycline-based regimen resulted in superior clinical outcome for women with node positive early breast cancer. In two large randomized studies the dose dense administration with G-CSF support of anthracycline-based and paclitaxel combination was superior to the same regimen administered every three weeks without growth factors as adjuvant therapy in women with axillary node positive breast cancer. In one randomized trial, docetaxel was proved superior to paclitaxel in women with metastatic breast cancer

Conditions

Interventions

DRUG

Docetaxel

Docetaxel 75 mg/m2 as an IV infusion over 1h every two weeks for 4 cycles

DRUG

Paclitaxel

Paclitaxel 175 mg/m2 as an IV infusion over 3hrs every two weeks for 4 cycles

DRUG

Epirubicin

Epirubicin 75 mg/m2 IV push on day 1 every 2 weeks for 4 cycles

DRUG

Cyclophosphamide

Cyclophosphamide 700 mg/m2 IV push on day 1 every 4 weeks

DRUG

5-fluoruracil

5-fluoruracil 700 mg/m2 IV push on day 1 every 4 weeks

DRUG

Granulocyte-colony stimulating growth factor

rhG-CSF 5 μg/kg/d on days 3-10 after each cycle

Sponsors & Collaborators

  • University Hospital of Crete

    collaborator OTHER

  • Hellenic Oncology Research Group

    lead OTHER

Principal Investigators

  • Dimitris Mavrudis, MD · University Hospital of Crete

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2004-08-31
Primary Completion
2007-10-31
Completion
2007-10-31

Countries

  • Greece

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 NCT00431080 on ClinicalTrials.gov