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

NCT00615602 | Completed Phase 3

• 1 other identifier: CT/04.23
• Study Type: interventional
• Target: 489
• Locations: 1 country
• Sites: 10

Brief 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

Breast Cancer

Keywords

Early breast cancer; Axillary node positive; HER2 overexpression; Adjuvant chemotherapy; Dose dense; Docetaxel; Trastuzumab; FEC

Outcome Measures

Primary Outcomes (1)

• 3-year disease-free survival

  3 years

Secondary Outcomes (4)

• Overall survival

  5 years

• Recurrence rate

  Relapses by the time of 3-years follow up

• Τoxicity profile

  Toxicity assessment on each chemotherapy cycle

• Quality of life between the two treatment arms

  Assessment every two cycles

Study Arms (2)

1

EXPERIMENTAL

FEC -\> TXT+H 12m

Drug: Docetaxel; Drug: Trastuzumab; Drug: Epirubicin; Drug: Cyclophosphamide; Drug: 5-fluoruracil; Drug: Granulocyte-colony stimulating growth factor

2

EXPERIMENTAL

FEC -\> TXT+H 6m

Drug: Docetaxel; Drug: Epirubicin; Drug: Cyclophosphamide; Drug: 5-fluoruracil; Drug: Granulocyte-colony stimulating growth factor; Drug: Trastuzumab

Interventions

Docetaxel DRUG

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

Also known as: Taxotere

1; 2

Trastuzumab DRUG

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

Also known as: Herceptin

1

Epirubicin DRUG

Epirubicin 75 mg/m2 IV push on day 1 every 2 weeks for 4 cycles

Also known as: Farmorubicin

1; 2

Cyclophosphamide DRUG

Cyclophosphamide 700 mg/m2 IV push on day 1 every 4 weeks

Also known as: Endoxan

1; 2

5-fluoruracil DRUG

5-fluoruracil 700 mg/m2 IV push on day 1 every 4 weeks

Also known as: 5-FU

1; 2

Granulocyte-colony stimulating growth factor DRUG

rhG-CSF 5 μg/kg/d on days 3-10 after each cycle

Also known as: Granocyte, Neulasta

1; 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hellenic Oncology Research Group: lead
• University Hospital of Crete: collaborator

Study Sites (10)

University Hospital of Crete

Heraklion, Crete, 71110, Greece

Location

University General Hospital of Alexandroupolis, Dep of Medical Oncology

Alexandroupoli, Greece

Location

"IASO" General Hospital of Athens, 1st Dep of Medical Oncology

Athens, Greece

Location

"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine

Athens, Greece

Location

"Marika Iliadis" Hospital of Athens, Dep of Medical Oncology

Athens, Greece

Location

401 Military Hospital of Athens

Athens, Greece

Location

Air Forces Military Hospital of Athens

Athens, Greece

Location

State General Hospital of Larissa, Dep of Medical Oncology

Larissa, Greece

Location

"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology

Piraeus, Greece

Location

"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology

Thessaloniki, Greece

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Docetaxel; Trastuzumab; Epirubicin; Cyclophosphamide; Fluorouracil; Granulocyte Colony-Stimulating Factor; Lenograstim; pegfilgrastim

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Biological Factors

Study Officials

• Dimitris Mavrudis, MD

  University Hospital of Crete

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2008
• First Posted: February 14, 2008
• Study Start: October 1, 2004
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: March 4, 2015

Record last verified: 2015-03

Locations

GR (10)