CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
epirubicin +3 moredrug
Likely dose
Epirubicin 100 mg/m² every 2 weeks for 4 cycles, cyclophosphamide 600 mg/m² every 2 weeks for 4 cycles, docetaxel 75 mg/m² every 2 weeks for 4 cycles, trastuzumab 6 mg/kg loading dose then 4 mg/kg maintenance every 2 weeks for 4 treatmentsAI-extracted
Key inclusion· 6
  • ✓HER2-positive breast cancer (documented by core biopsy)
  • ✓Stage IIA-IIIC or high-risk node-negative disease
  • ✓Normal cardiac function and adequate hematologic function
  • ✓No evidence of metastatic disease
Key exclusion· 7
  • ✕Uncontrolled intercurrent disease or active infection
  • ✕Known sensitivity to E. coli-derived proteins or polysorbate 80
  • ✕Pre-existing peripheral neuropathy greater than Grade 1
  • ✕Prior malignancy within 5 years (except surgically cured nonmelanomatous skin cancer, in-situ cervical carcinoma, or in-situ breast carcinoma)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00270894
NCT00270894Phase 2Completed
CompareCT.gov

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

Accelerated Community Oncology Research Network·interventional·Posted Dec 29, 2005·Updated Mar 20, 2012

In Brief

A Phase 2 clinical trial evaluating epirubicin, cyclophosphamide, and 2 other interventions for Breast Neoplasm. Completed, enrolled 30 participants across 7 sites.

Detailed 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)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Neoplasm
CountriesUnited States
CollaboratorsAventis Pharmaceuticals

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 29, 2005
Enrollment StartNov 1, 2005
Primary CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 20.5 years ago

Interventions

epirubicindrug

epirubicin (100 mg/m\^2) every 2 weeks for 4 cycles

cyclophosphamidedrug

cyclophosphamide (600 mg/m\^2) every 2 weeks for 4 cycles

docetaxeldrug

docetaxel (75 mg/m\^2) every 2 weeks for 4 cycles

trastuzumabdrug

trastuzumab (6 mg/kg \[loading dose\] once then 4 mg/kg \[maintenance dose\]) every 2 weeks for 4 treatments