CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 112 enrolled
Drug / intervention
cyclophosphamide +3 moredrug
Likely dose
Not stated in 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/NCT01106898
NCT01106898Phase 2Completed

A Phase II Study of Adjuvant Therapy Using a Regimen of Cyclophosphamide, Paclitaxel With or Without Trastuzumab in Stage I-II Breast Cancer Patients

University of Nebraska·interventional·Posted Apr 20, 2010·Updated Sep 28, 2023

In Brief

A Phase 2 clinical trial evaluating cyclophosphamide, paclitaxel, and 2 other interventions for Stage IA Breast Cancer and 3 related conditions. Completed, enrolled 112 participants across 2 sites.

Detailed Summary

This phase II trial studies the side effects and how well giving cyclophosphamide and paclitaxel with or without trastuzumab works in treating patients with stage I-II breast cancer who have undergone surgery. Drugs used in chemotherapy, such as cyclophosphamide and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving monoclonal antibody therapy, such as trastuzumab, with chemotherapy may kill more tumor cells. Giving these treatments after surgery may kill any tumor cells that remain after surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 20, 2010
Enrollment StartMar 24, 2010
Primary CompletionSep 28, 2015
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 16.2 years ago

Interventions

cyclophosphamidedrug

Given IV

paclitaxeldrug

Given IV

trastuzumabbiological

Given IV

laboratory biomarker analysisother

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