NCT00431080 - Randomized Phase III Trial Comparing Sequential Administration of FE75C Followed by Docetaxel Versus Paclitaxel as Adjuvant Chemotherapy in Axillary Lymph Node (+) Breast Cancer | Biotech Hunter

Enrollment

478

Participants

Timeline

Start Date

August 31, 2004

Primary Completion Date

October 31, 2007

Study Completion Date

October 31, 2007

Conditions

Breast Cancer

Interventions

DRUG

Docetaxel

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

DRUG

Paclitaxel

Paclitaxel 175 mg/m2 as an IV infusion over 3hrs 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

Trial Locations (10)

University Hospital of Crete, Heraklion

University General Hospital of Alexandroupolis, Dep of Medical Oncology, Alexandroupoli

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

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

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

401 Military Hospital of Athens, Athens

Air Forces Military Hospital of Athens, Athens

State General Hospital of Larissa, Dep of Medical Oncology, Larissa

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

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