CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 41 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/NCT00499122
NCT00499122Phase 2Completed

Phase II Study of Neoadjuvant Treatment With NOV-002 in Combination With Doxorubicin and Cyclophosphamide Followed by Docetaxel in Patients With Stages IIB-IIIC Breast Cancer

University of Miami·interventional·Posted Jul 11, 2007·Updated Jan 2, 2018

In Brief

A Phase 2 clinical trial evaluating Cyclophosphamide, Docetaxel, and 2 other interventions for Breast Cancer. Completed, enrolled 41 participants across 2 sites.

Detailed Summary

RATIONALE: Oxidized glutathione (NOV-002) may stimulate the immune system in different ways and stop tumor cells from growing. Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving NOV-002 together with chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase II trial is studying how well giving oxidized glutathione (NOV-002) together with doxorubicin and cyclophosphamide followed by docetaxel works in treating women with newly diagnosed stage II or stage III breast cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 11, 2007
Enrollment StartJun 4, 2007
Primary CompletionApr 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 19.0 years ago

Interventions

Cyclophosphamidedrug

Docetaxeldrug

Doxorubicindrug

NOV 002drug