Sequential Administration of FE75C and Docetaxel Versus Docetaxel/Cyclophosphamide in HER-2 Negative, Node Positive Breast Cancer

May 13, 2014 updated by: Hellenic Oncology Research Group

A Multicenter Randomized Study Comparing the Dose Dense, G-CSF-supported Sequential Administration of FE75C Followed by Docetaxel Versus Docetaxel/Cyclophosphamide Doublet as Adjuvant Chemotherapy in Women With HER-2 Negative, Axillary Lymph Node Positive Breast Cancer

In this trial investigators propose to assess the dose dense, G-CSF supported sequential administration of 4 cycles of FEC followed by 4 cycles of docetaxel versus 6 cycles of docetaxel/cyclophosphamide as adjuvant chemotherapy in women with HER-2 negative, axillary lymph node positive breast cancer

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Anthracycline-containing regimens are recommended as adjuvant treatment for women with node positive breast cancer. At least five large randomized clinical trials demonstrated that the addition or sequential administration of a taxane (paclitaxel or docetaxel) to an anthracycline-based regimen resulted in superior clinical outcome for women with node positive or high risk node-negative 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.

Data from at least one trial suggest that four cycles of a non-anthracycline but taxane-containing adjuvant regimen (docetaxel plus cyclophosphamide) provide outcomes that are at least as good, if not better than four cycles of doxorubicin/cyclophosphamide combination.

Study Type

Interventional

Enrollment (Actual)

650

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Alexandroupolis, Greece
        • University General Hospital of Alexandroupolis, Dep of Medical Oncology
      • Athens, Greece
        • "Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
      • Athens, Greece
        • "IASO" General Hospital of Athens, 1st Dep of Medical Oncology
      • 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
      • Larissa, Greece
        • State General Hospital of Larissa, Dep of Medical Oncology
      • Piraeus, Greece
        • "Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology
      • Thessaloniki, Greece
        • "Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
    • Crete
      • Heraklion, Crete, Greece, 71110
        • University Hospital of Crete

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
FEC -> TXT
Drug: Docetaxel
ARM A: Docetaxel 75 mg/m2 as an IV infusion over 1h on day 1 every 2 weeks for 4 cycles ARM B: Docetaxel 75 mg/m2 as an IV infusion over 1h on day 1 every 3 weeks for 6 cycles
Other Names:
  • Taxotere
Drug: Epirubicin
ARM A: Epirubicin 75 mg/m2 IV push on day 1 every 2 weeks for 4 cycles
Other Names:
  • Farmorubicin
Drug: Cyclophosphamide
ARM A: Cyclophosphamide 500 mg/m2 IV push on day 1 every 2 weeks for 4 cycles ARM B: Cyclophosphamide 600 mg/m2 IV push on day 1 every 3 weeks for 6 cycles
Other Names:
  • Endoxan
Drug: 5-fluoruracil
ARM A: 5-fluoruracil 500 mg/m2 IV push on day 1 every 2 weeks for 4 cycles
Other Names:
  • 5-FU
Drug: Granulocyte-colony stimulating growth factor
rhG-CSF 5 μg/kg/d on days 3-10 after each cycle
Other Names:
  • Neulasta
  • Granocyte
Experimental: B
Docetaxel/Cyclophosphamide (TC)
Drug: Docetaxel
ARM A: Docetaxel 75 mg/m2 as an IV infusion over 1h on day 1 every 2 weeks for 4 cycles ARM B: Docetaxel 75 mg/m2 as an IV infusion over 1h on day 1 every 3 weeks for 6 cycles
Other Names:
  • Taxotere
Drug: Cyclophosphamide
ARM A: Cyclophosphamide 500 mg/m2 IV push on day 1 every 2 weeks for 4 cycles ARM B: Cyclophosphamide 600 mg/m2 IV push on day 1 every 3 weeks for 6 cycles
Other Names:
  • Endoxan
Drug: Granulocyte-colony stimulating growth factor
rhG-CSF 5 μg/kg/d on days 3-10 after each cycle
Other Names:
  • Neulasta
  • Granocyte

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
3-year disease-free survival
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival
Time Frame: 3 years
3 years
Recurrence rate
Time Frame: Relapses by the time of 3-years follow up
Relapses by the time of 3-years follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hellenic Oncology Research Group

Collaborators

University Hospital of Crete

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

November 9, 2013

First Submitted That Met QC Criteria

November 9, 2013

First Posted (Estimate)

November 15, 2013

Study Record Updates

Last Update Posted (Estimate)

May 14, 2014

Last Update Submitted That Met QC Criteria

May 13, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT/07.17

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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