At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 66 enrolled
Drug / intervention
Nanoparticle albumin bound paclitaxel followed by FECdrug
Likely dose
Nanoparticle albumin bound paclitaxel followed by FEC 100 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2 Study of Neoadjuvant Chemotherapy With Sequential Weekly Nanoparticle Albumin Bound Paclitaxel (Abraxane) Followed by 5-Fluorouracil, Epirubicin, Cyclophosphamide (FEC) in Locally Advanced Breast Cancer
In Brief
A Phase 2 clinical trial evaluating Nanoparticle albumin bound paclitaxel followed by FEC for Breast Neoplasms. Completed, enrolled 66 participants across 1 site.
Detailed Summary
The purpose of this study is to learn how breast cancer tumors respond to a drug called Abraxane followed by a combination of 3 chemotherapy drugs commonly used for breast cancer.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Neoplasms
CountriesUnited States
CollaboratorsCelgene Corporation
Timeline
Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartApr 2005
First PostedMay 2005
Primary CompletionDec 2006
Study CompletionJul 2008
TodayJul 2026
First PostedMay 13, 2005
Enrollment StartApr 1, 2005
Primary CompletionDec 1, 2006
Study CompletionJul 1, 2008
TodayJul 1, 2026
Enrollment to primary: 1.7 yearsPosted 21.1 years ago
Interventions
Nanoparticle albumin bound paclitaxel followed by FECdrug
Nanoparticle albumin bound paclitaxel 100 mg/m2 IV for 30 minutes once weekly for 12 weeks followed by FEC (5-FU 500mg/m2 IV push; epirubicin 100 mg/m2 IV over 15 min. \[or if given with trastuzumab 75 mg/m2 IV over 15 min.\]; cyclophosphamide 500 mg/m2 IV over 30 min.) on Day 1 every 21 days