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

March 3, 2015 updated by: Hellenic Oncology Research Group

A Multicenter Randomized Phase III Study Comparing 6 Versus 12 Months of Trastuzumab in Combination With Dose Dense Docetaxel Following FE75C as Adjuvant Treatment of Women With Axillary Lymph Node Positive Breast Cancer Over-expressing HER2

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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. Trastuzumab (anti-HER2 monoclonal antibody) in combination with paclitaxel was superior to paclitaxel alone in women with metastatic breast cancer overexpressing HER2

Study Type

Interventional

Enrollment (Actual)

489

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 to 75 years (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
  • HER2/c-neu over expression should be documented by either immunohistochemistry (score 3+) or FISH/CISH positivity. A score of 2+ by immunohistochemistry is acceptable only if FISH/CISH positive
  • 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 (N0 with HER2/c-neu over expression are also eligible)
  • 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%). Normal electrocardiogram and absence of significant heart disease
  • 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
Experimental: 1
FEC -> TXT+H 12m
Drug: Granulocyte-colony stimulating growth factor
rhG-CSF 5 μg/kg/d on days 3-10 after each cycle
Other Names:
  • Neulasta
  • Granocyte
Drug: Docetaxel
Docetaxel 75 mg/m2 as an IV infusion over 1h every two weeks for 4 cycles
Other Names:
  • Taxotere
Drug: Epirubicin
Epirubicin 75 mg/m2 IV push on day 1 every 2 weeks for 4 cycles
Other Names:
  • Farmorubicin
Drug: Cyclophosphamide
Cyclophosphamide 700 mg/m2 IV push on day 1 every 4 weeks
Other Names:
  • Endoxan
Drug: 5-fluoruracil
5-fluoruracil 700 mg/m2 IV push on day 1 every 4 weeks
Other Names:
  • 5-FU
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
Other Names:
  • Herceptin
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
Other Names:
  • Herceptin
Experimental: 2
FEC -> TXT+H 6m
Drug: Granulocyte-colony stimulating growth factor
rhG-CSF 5 μg/kg/d on days 3-10 after each cycle
Other Names:
  • Neulasta
  • Granocyte
Drug: Docetaxel
Docetaxel 75 mg/m2 as an IV infusion over 1h every two weeks for 4 cycles
Other Names:
  • Taxotere
Drug: Epirubicin
Epirubicin 75 mg/m2 IV push on day 1 every 2 weeks for 4 cycles
Other Names:
  • Farmorubicin
Drug: Cyclophosphamide
Cyclophosphamide 700 mg/m2 IV push on day 1 every 4 weeks
Other Names:
  • Endoxan
Drug: 5-fluoruracil
5-fluoruracil 700 mg/m2 IV push on day 1 every 4 weeks
Other Names:
  • 5-FU
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
Other Names:
  • Herceptin
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
Other Names:
  • Herceptin

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: 5 years
5 years
Recurrence rate
Time Frame: Relapses by the time of 3-years follow up
Relapses by the time of 3-years follow up
Τoxicity profile
Time Frame: Toxicity assessment on each chemotherapy cycle
Toxicity assessment on each chemotherapy cycle
Quality of life between the two treatment arms
Time Frame: Assessment every two cycles
Assessment every two cycles

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

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, 2004

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

February 1, 2008

First Submitted That Met QC Criteria

February 1, 2008

First Posted (Estimate)

February 14, 2008

Study Record Updates

Last Update Posted (Estimate)

March 4, 2015

Last Update Submitted That Met QC Criteria

March 3, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT/04.23

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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