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Six vs 12 Months of Trastuzumab With Docetaxel Following FEC as Adjuvant Treatment in N+ Breast Cancer

NCT00615602 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 489

Last updated 2015-03-04

No results posted yet for this study

Summary

This trial will compare 6 versus 12 months of trastuzumab in combination with dose dense docetaxel following FE75C as adjuvant chemotherapy in women with axillary lymph node positive breast cancer overexpressing HER2

Conditions

Interventions

DRUG

Docetaxel

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

DRUG

Trastuzumab

Trastuzumab 6 mg/Kg IV over 30 min every two weeks for 4 cycles. Subsequently,trastuzumab 6 mg/Kg IV over 30 min for 12 months

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

DRUG

Trastuzumab

Trastuzumab 6mg/Kg IV over 30 min every 2 weeks for 4 cycles. Subsequently, trastuzumab 6mg/Kg IV over 30 min for 6 months

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
2004-10-31
Primary Completion
2012-05-31
Completion
2012-05-31

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 NCT00615602 on ClinicalTrials.gov