Sutent Neoadjuvant Study
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.
Drug: sunitinib alone
Drug: sunitinib plus paclitaxel
Drug: doxorubicin and cyclophosphamide
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Exploratory Study of the Biological and Clinical Activity of Sunitinib Malate as a Component of Neoadjuvant Therapy for Breast Cancer|
- To measure changes in interstitial fluid pressure (IFP) induced by sunitinib monotherapy [ Time Frame: screening through cycle 6 ] [ Designated as safety issue: No ]
- To measure changes in interstitial fluid pressure (IFP) induced by paclitaxel plus sunitinib after sunitinib monotherapy [ Time Frame: screening through cycle 6 ] [ Designated as safety issue: No ]
- • To assess the pathological complete response (pCR) rate for patients treated with sunitinib/paclitaxel followed by AC as neoadjuvant therapy for breast cancer [ Time Frame: screening through surgery ] [ Designated as safety issue: No ]
- To evaluate the safety of paclitaxel plus sunitinib when given in combination as neoadjuvant therapy [ Time Frame: screening through surgery ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2008|
|Estimated Study Completion Date:||January 2014|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
The study will be conducted in 3 sequential treatment segments.
Drug: sunitinib alone
sunitinib alone (segment 1): During the first segment, patients will receive single-agent sunitinib for 2 weeks.Drug: sunitinib plus paclitaxel
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.Drug: doxorubicin and cyclophosphamide
doxorubicin and cyclophosphamide (Segment 3): Following Segment 2, patients will receive 4 cycles (8 weeks) of neoadjuvant treatment with AC.
|United States, Indiana|
|Indiana University Melvin and Bren Simon Cancer Center|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Kathy Miller, MD||Indiana University School of Medicine|