CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 68 enrolled
Drug / intervention
sunitinib malate +7 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/NCT00513695
NCT00513695Phase 2Completed

A Phase II Study Evaluating the Safety and Efficacy of Sunitinib Maleate in Combination With Weekly Paclitaxel Followed by Doxorubicin and Daily Oral Cyclophosphamide Plus G-CSF as Neoadjuvant Chemotherapy for Locally Advanced or Inflammatory Breast Cancer

University of Washington·interventional·Posted Aug 9, 2007·Updated Aug 7, 2019

In Brief

A Phase 2 clinical trial evaluating sunitinib malate, paclitaxel, and 6 other interventions for Inflammatory Breast Cancer and 5 related conditions. Completed, enrolled 68 participants across 7 sites.

Detailed Summary

This phase II trial studies how well giving sunitinib malate together with paclitaxel, doxorubicin hydrochloride, and cyclophosphamide before surgery works in treating patients with stage IIB-IIIC breast cancer. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. Drugs used in chemotherapy, such as paclitaxel, doxorubicin hydrochloride, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sunitinib malate together with combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed

Study Details

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

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 9, 2007
Enrollment StartJun 1, 2007
Primary CompletionAug 1, 2012
Study CompletionOct 16, 2017
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 18.9 years ago

Interventions

sunitinib malatedrug

Given PO

paclitaxeldrug

Given IV

doxorubicin hydrochloridedrug

Given IV

cyclophosphamidedrug

Given PO

filgrastimbiological

Given SC

therapeutic conventional surgeryprocedure

Undergo surgery

laboratory biomarker analysisother

Correlative studies

flow cytometryother

Correlative studies