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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00431080
First Posted: February 5, 2007
Last Update Posted: January 21, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University Hospital of Crete
Information provided by:
Hellenic Oncology Research Group
  Purpose
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

Condition Intervention Phase
Breast Cancer Drug: Docetaxel Drug: Paclitaxel Drug: Epirubicin Drug: Cyclophosphamide Drug: 5-fluoruracil Drug: Granulocyte-colony stimulating growth factor Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Randomized Study Comparing the Dose Dense, G-CSF-Supported Sequential Administration of FE75C Followed by Docetaxel Versus Paclitaxel as Adjuvant Chemotherapy in Women With Axillary Lymph Node Positive Breast Cancer

Resource links provided by NLM:


Further study details as provided by Hellenic Oncology Research Group:

Primary Outcome Measures:
  • 3-year disease-free survival [ Time Frame: 3 years ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: 3 years ]
  • Recurrence rate [ Time Frame: Relapses by the time of 3-years follow up ]
  • Τoxicity profile [ Time Frame: Toxicity assessment on each chemotherapy cycle ]
  • Quality of life between the two treatment arms [ Time Frame: Assessment every two cycles ]

Enrollment: 478
Study Start Date: August 2004
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
FEC -> TXT
Drug: Docetaxel
Docetaxel 75 mg/m2 as an IV infusion over 1h every two weeks for 4 cycles
Other Name: Taxotere
Drug: Epirubicin
Epirubicin 75 mg/m2 IV push on day 1 every 2 weeks for 4 cycles
Other Name: Farmorubicin
Drug: Cyclophosphamide
Cyclophosphamide 700 mg/m2 IV push on day 1 every 4 weeks
Other Name: Endoxan
Drug: 5-fluoruracil
5-fluoruracil 700 mg/m2 IV push on day 1 every 4 weeks
Other Name: 5-FU
Drug: Granulocyte-colony stimulating growth factor
rhG-CSF 5 μg/kg/d on days 3-10 after each cycle
Other Names:
  • Granocyte
  • Neulasta
Experimental: 2
FEC -> TXL
Drug: Paclitaxel
Paclitaxel 175 mg/m2 as an IV infusion over 3hrs every two weeks for 4 cycles
Other Name: Taxol
Drug: Epirubicin
Epirubicin 75 mg/m2 IV push on day 1 every 2 weeks for 4 cycles
Other Name: Farmorubicin
Drug: Cyclophosphamide
Cyclophosphamide 700 mg/m2 IV push on day 1 every 4 weeks
Other Name: Endoxan
Drug: 5-fluoruracil
5-fluoruracil 700 mg/m2 IV push on day 1 every 4 weeks
Other Name: 5-FU
Drug: Granulocyte-colony stimulating growth factor
rhG-CSF 5 μg/kg/d on days 3-10 after each cycle
Other Names:
  • Granocyte
  • Neulasta

Detailed Description:
This trial will compare the dose dense, G-CSF supported sequential administration of 4 cycles of 5-Fluoruracil (F) plus Epirubicin (E 75mg/m2) plus Cyclofosfamide (C) followed by 4 cycles of docetaxel versus 4 cycles of paclitaxel as adjuvant chemotherapy in women with axillary lymph node positive breast cancer
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women with histologically-confirmed unilateral invasive ductal or lobular breast adenocarcinoma
  • Within 60 days after the surgical excision of the primary tumor with tumor-free operation margins; at least 10 axillary lymph nodes have to be removed.
  • Tumor involvement of at least one axillary lymph node
  • Absence of any clinical or radiological evidence of local or metastatic disease
  • Premenopausal or postmenopausal women aged 18-75 years old
  • Adequate bone marrow function (absolute neutrophil count >1500/mm3, platelet count >100.000/mm3, hemoglobin >10gr/mm3)
  • Adequate liver (bilirubin <1.0 times upper limit of normal and SGOT/SGPT <2.5 times upper limit of normal) and renal function (creatinine <1.5mg/dl)
  • Adequate cardiac function (LVEF>50%)
  • Written informed consent

Exclusion Criteria:

  • Positive pregnancy test.
  • Psychiatric illness or social situation that would preclude study compliance.
  • Other concurrent uncontrolled illness.
  • Prior or concurrent antineoplastic therapy e.g. hormonal therapy, radiation therapy, chemotherapy, biological agents.
  • Previous history of other invasive malignancy other than non-melanomatous skin cancer.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00431080


Locations
Greece
University Hospital of Crete
Heraklion, Crete, Greece, 71110
University General Hospital of Alexandroupolis, Dep of Medical Oncology
Alexandroupolis, Greece
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology
Athens, Greece
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
Athens, Greece
"Marika Iliadis" Hospital of Athens, Dep of Medical Oncology
Athens, Greece
401 Military Hospital of Athens
Athens, Greece
Air Forces Military Hospital of Athens
Athens, Greece
State General Hospital of Larissa, Dep of Medical Oncology
Larissa, Greece
"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology
Piraeus, Greece
"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
Thessaloniki, Greece
Sponsors and Collaborators
Hellenic Oncology Research Group
University Hospital of Crete
Investigators
Principal Investigator: Dimitris Mavrudis, MD University Hospital of Crete
  More Information

Responsible Party: D.Mavrudis, Hellenic Oncology Research Group
ClinicalTrials.gov Identifier: NCT00431080     History of Changes
Other Study ID Numbers: CT/04.22
First Submitted: February 2, 2007
First Posted: February 5, 2007
Last Update Posted: January 21, 2008
Last Verified: January 2008

Keywords provided by Hellenic Oncology Research Group:
Early breast cancer
Axillary node positive
Adjuvant chemotherapy
Dose dense
Docetaxel
Paclitaxel
FEC

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Docetaxel
Albumin-Bound Paclitaxel
Cyclophosphamide
Epirubicin
Mitogens
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors