Six vs 12 Months of Transtuzumab With Docetaxel Following FEC as Adjuvant Treatment in N+ Breast Cancer - Full Text View

Sponsors and Collaborators:	Hellenic Oncology Research Group University Hospital of Crete
Information provided by:	Hellenic Oncology Research Group
ClinicalTrials.gov Identifier:	NCT00615602

Purpose

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

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

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Cyclophosphamide Docetaxel Fluorouracil Epirubicin hydrochloride Epirubicin Pegfilgrastim Trastuzumab Lenograstim

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	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 Overexpressing HER2

Further study details as provided by Hellenic Oncology Research Group:

Primary Outcome Measures:

3-year disease-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Recurrence rate [ Time Frame: Relapses by the time of 3-years follow up ] [ Designated as safety issue: No ]
Τoxicity profile [ Time Frame: Toxicity assessment on each chemotherapy cycle ] [ Designated as safety issue: Yes ]
Quality of life between the two treatment arms [ Time Frame: Assessment every two cycles ] [ Designated as safety issue: No ]

Estimated Enrollment:	478
Study Start Date:	October 2004
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental FEC -> TXT+H 12m	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
2: Experimental FEC -> TXT+H 6m	Drug: Docetaxel Docetaxel 75 mg/m2 as an IV infusion over 1h 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 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

Arms

Assigned Interventions

1: Experimental

FEC -> TXT+H 12m

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

2: Experimental

FEC -> TXT+H 6m

Drug: Docetaxel

Docetaxel 75 mg/m2 as an IV infusion over 1h 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

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

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

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Women with histologically-confirmed unilateral invasive ductal or lobular breast adenocarcinoma
HER2/c-neu overexpression 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
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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00615602

Contacts

Contact: Dora Hatzidaki	+302810392570	dorachat@med.uoc.gr
Contact: Sofia Mavraki	+30281392987	maurakh@gmail.com

Locations

Greece
"Marika Iliadis" Hospital of Athens, Dep of Medical Oncology	Recruiting
Athens, Greece
Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Nikos Malamos, MD
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine	Recruiting
Athens, Greece
Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Aris Polyzos, MD
"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology	Recruiting
Piraeus, Greece
Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Nikos Ziras, MD
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology	Recruiting
Athens, Greece
Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Stelios Giassas, MD
401 Military Hospital of Athens	Recruiting
Athens, Greece
Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Charalampos Christophillakis, MD
Air Forces Military Hospital of Athens	Recruiting
Athens, Greece
Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Nikos Kentepozidis, MD
State General Hospital of Larissa, Dep of Medical Oncology	Recruiting
Larissa, Greece
Contact: Nikoleta Karkatzou +302106448666 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Athanasios Athanasiadis, MD
University General Hospital of Alexandroupolis, Dep of Medical Oncology	Recruiting
Alexandroupolis, Greece
Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Stelios Kakolyris, MD
"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology	Recruiting
Thessaloniki, Greece
Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Ioannis Boukovinas, MD
Greece, Crete
University Hospital of Crete	Recruiting
Heraklion, Crete, Greece, 71110
Contact: Dora Hatzidaki +302810392570 dorachat@med.uoc.gr
Contact: Eva Maragkoudaki +302810392857 dorachat@med.uoc.gr
Principal Investigator: Dimitris Mavrudis, MD

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:	Hellenic Oncology Research Group ( D.Mavrudis )
Study ID Numbers:	CT/04.23
Study First Received:	February 1, 2008
Last Updated:	July 11, 2008
ClinicalTrials.gov Identifier:	NCT00615602
Health Authority:	Greece: National Organization of Medicines

Keywords provided by Hellenic Oncology Research Group:

Early breast cancer
Axillary node positive
HER2 overexpression
Adjuvant chemotherapy

Dose dense
Docetaxel
Trastuzumab
FEC

Study placed in the following topic categories:

Docetaxel
Skin Diseases
Lenograstim
Fluorouracil
Trastuzumab

Breast Neoplasms
Cyclophosphamide
Epirubicin
Breast Diseases

Additional relevant MeSH terms:

Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions

Neoplasms
Neoplasms by Site
Therapeutic Uses
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Alkylating Agents

ClinicalTrials.gov processed this record on January 14, 2009