CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 63 enrolled
Drug / intervention
nab paclitaxel +2 moredrug
Likely dose
nab paclitaxel 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.

Search/NCT00629499
NCT00629499Phase 2Completed
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Phase II Trial of Nanoparticle Albumin-Bound (Nab) Paclitaxel/Cyclophosphamide in Early-Stage Breast Cancer (With Trastuzumab in HER2 Positive Patients)

SCRI Development Innovations, LLC·interventional·Posted Mar 6, 2008·Updated Nov 24, 2021

In Brief

A Phase 2 clinical trial evaluating nab paclitaxel, Cyclophosphamide, and 1 other intervention for Breast Cancer. Completed, enrolled 63 participants across 10 sites.

Detailed Summary

This is a non-randomized, Phase II study. Efficacy is not a primary endpoint in this study; however, progression-free survival will be followed and determined for the patients in this study. Approximately 50 patients are planned to be enrolled in this study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
CollaboratorsCelgene Corporation

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 6, 2008
Enrollment StartApr 1, 2008
Primary CompletionOct 1, 2008
Study CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 18.3 years ago

Interventions

nab paclitaxeldrug

100 mg/m2 of intravenous (IV) nab paclitaxel weekly (i.e., on Days 1, 8, and 15 of each 3 week treatment cycle)

Cyclophosphamidedrug

600 mg/m2 of IV cyclophosphamide

Trastuzumabdrug

8 mg/kg loading dose of IV trastuzumab will be administered on Day 1, followed by doses of 6 mg/kg IV trastuzumab once every 3 weeks.