NCT00270894

Neoadjuvant Chemotherapy + Herceptin in HER2 Positive Stage II-III Breast Cancer Patients

Pilot Trial of Sequential Dose-Dense Neoadjuvant Chemotherapy Plus Herceptin in HER2 Positive Stage II-III Breast Cancer Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Accelerated Community Oncology Research Network · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the effectiveness and tolerability of the combination of the following medications given every two weeks in HER2 positive breast cancer patients: * trastuzumab (Herceptin) * epirubicin (Ellence) * cyclophosphamide (Cytoxan) * docetaxel (Taxotere)

Detailed description

This is an investigator-initiated, Phase II, non-randomized, single-arm, prospective treatment study. The study will consist of neoadjuvant treatment period (weeks 1 to 20), surgical evaluation period (weeks 20 to 24), and a post-surgical/follow-up period (approximately 3 years). Subjects will be treated on an outpatient basis. Neoadjuvant therapy will consist of epirubicin + cyclophosphamide given every 2 weeks for four cycles followed by a three week break. Subjects will then receive docetaxel every two weeks for four cycles + trastuzumab (one loading dose) then maintenance dose every 2 weeks for 4 treatments.

Conditions

• Breast Neoplasm

Interventions

Type	Name	Description
DRUG	epirubicin	epirubicin (100 mg/m\^2) every 2 weeks for 4 cycles
DRUG	cyclophosphamide	cyclophosphamide (600 mg/m\^2) every 2 weeks for 4 cycles
DRUG	docetaxel	docetaxel (75 mg/m\^2) every 2 weeks for 4 cycles
DRUG	trastuzumab	trastuzumab (6 mg/kg \[loading dose\] once then 4 mg/kg \[maintenance dose\]) every 2 weeks for 4 treatments

Timeline

• Start date: 2005-11-01
• Primary completion: 2011-08-01
• Completion: 2011-08-01
• First posted: 2005-12-29
• Last updated: 2012-03-20
• Results posted: 2012-03-12

Locations

7 sites across 1 country: United States