Randomized Phase III Trial Comparing Sequential Administration of FE75C Followed by Docetaxel Versus Paclitaxel as Adjuvant Chemotherapy in Axillary Lymph Node (+) Breast Cancer

NCT00431080 | Completed Phase 3

• 1 other identifier: CT/04.22
• Study Type: interventional
• Target: 478
• Locations: 1 country
• Sites: 10

Brief Summary

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

Conditions

Breast Cancer

Keywords

Early breast cancer; Axillary node positive; Adjuvant chemotherapy; Dose dense; Docetaxel; Paclitaxel; FEC

Outcome Measures

Primary Outcomes (1)

• 3-year disease-free survival

  3 years

Secondary Outcomes (4)

• Overall survival

  3 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

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

2

EXPERIMENTAL

FEC -\> TXL

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

Interventions

Docetaxel DRUG

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

Also known as: Taxotere

1

Paclitaxel DRUG

Paclitaxel 175 mg/m2 as an IV infusion over 3hrs every two weeks for 4 cycles

Also known as: Taxol

2

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
• 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

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; Paclitaxel; 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; 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; Amino Acids, Peptides, and Proteins; Proteins; 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

Study Record Dates

• First Submitted: February 2, 2007
• First Posted: February 5, 2007
• Study Start: August 1, 2004
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: January 21, 2008

Record last verified: 2008-01

Locations

GR (10)