NCT00615602

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

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 Over-expressing HER2

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 489 (actual)
• Sponsor: Hellenic Oncology Research Group · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

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

Conditions

• Breast Cancer

Interventions

Type	Name	Description
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
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

Timeline

• Start date: 2004-10-01
• Primary completion: 2012-05-01
• Completion: 2012-05-01
• First posted: 2008-02-14
• Last updated: 2015-03-04

Locations

10 sites across 1 country: Greece