CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 23 enrolled
Drug / intervention
sunitinib alone +2 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/NCT00656669
NCT00656669N/ACompleted

An Exploratory Study of the Biological and Clinical Activity of Sunitinib Malate as a Component of Neoadjuvant Therapy for Breast Cancer

Indiana University·interventional·Posted Apr 11, 2008·Updated May 23, 2023

In Brief

A clinical study evaluating sunitinib alone, sunitinib plus paclitaxel, and 1 other intervention for Breast Cancer. Completed, enrolled 23 participants across 1 site.

Detailed Summary

The combination of paclitaxel, doxorubicin, and cyclophosphamide is a standard neoadjuvant (given before surgery) treatment for patients that have either inoperable or operable breast cancer. This treatment can help shrink the tumors so they can be removed to help prevent the cancer from spreading to other parts of the body. This study is being done to test the impact of adding sunitinib as a single-agent (Segment 1), followed by sunitinib plus paclitaxel (Segment 2), followed by doxorubicin and cyclophosphamide (Segment 3). We hope the addition of sunitinib will make the treatment more effective, but we don't know if this is true.

Study Details

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

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 11, 2008
Enrollment StartApr 1, 2008
Primary CompletionSep 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 18.2 years ago

Interventions

sunitinib alonedrug

sunitinib alone (segment 1): During the first segment, patients will receive single-agent sunitinib for 2 weeks.

sunitinib plus paclitaxeldrug

sunitinib plus paclitaxel (Segment 2): Following Segment 1, patients will begin the second segment, 4 cycles (16 weeks) of neoadjuvant treatment with the combination of sunitinib and paclitaxel.

doxorubicin and cyclophosphamidedrug

doxorubicin and cyclophosphamide (Segment 3): Following Segment 2, patients will receive 4 cycles (8 weeks) of neoadjuvant treatment with AC.