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

Phase 3

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Docetaxel; Drug: Paclitaxel; Drug: Epirubicin; Drug: Cyclophosphamide; Drug: 5-fluoruracil; Drug: Granulocyte-colony stimulating growth factor

• Registration Number: NCT00431080
• Lead Sponsor: Hellenic Oncology Research Group

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

Detailed Description

This trial will compare the dose dense, G-CSF supported sequential administration of 4 cycles of 5-Fluoruracil (F) plus Epirubicin (E 75mg/m2) plus Cyclofosfamide (C) followed by 4 cycles of docetaxel versus 4 cycles of paclitaxel as adjuvant chemotherapy in women with axillary lymph node positive breast cancer

Study Timeline

• Study Start: 2004-08
• Study First Submitted: 2007-02-02
• Study First Submitted QC: 2007-02-02
• Study First Posted: 2007-02-05
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Status Verified: 2008-01
• Last Update Submitted: 2008-01-18
• Last Update Posted: 2008-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 478

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Docetaxel	FEC -\> TXT
1	Epirubicin	FEC -\> TXT
1	5-fluoruracil	FEC -\> TXT
1	Granulocyte-colony stimulating growth factor	FEC -\> TXT
2	5-fluoruracil	FEC -\> TXL
2	Granulocyte-colony stimulating growth factor	FEC -\> TXL
1	Cyclophosphamide	FEC -\> TXT
2	Paclitaxel	FEC -\> TXL
2	Epirubicin	FEC -\> TXL
2	Cyclophosphamide	FEC -\> TXL

Primary Outcome Measures

Name	Time	Method
3-year disease-free survival	3 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (10)

"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology; 🇬🇷 Piraeus, Greece

University General Hospital of Alexandroupolis, Dep of Medical Oncology; 🇬🇷 Alexandroupolis, Greece

"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine; 🇬🇷 Athens, Greece

"Marika Iliadis" Hospital of Athens, Dep of Medical Oncology; 🇬🇷 Athens, Greece

401 Military Hospital of Athens; 🇬🇷 Athens, Greece

State General Hospital of Larissa, Dep of Medical Oncology; 🇬🇷 Larissa, Greece

"IASO" General Hospital of Athens, 1st Dep of Medical Oncology; 🇬🇷 Athens, Greece

Air Forces Military Hospital of Athens; 🇬🇷 Athens, Greece

University Hospital of Crete; 🇬🇷 Heraklion, Crete, Greece

"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology; 🇬🇷 Thessaloniki, Greece