Exploratory Study of Sunitinib Malate as a Component of Neoadjuvant Therapy for Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00656669|
Recruitment Status : Completed
First Posted : April 11, 2008
Results First Posted : August 12, 2014
Last Update Posted : August 12, 2014
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: sunitinib alone Drug: sunitinib plus paclitaxel Drug: doxorubicin and cyclophosphamide||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Exploratory Study of the Biological and Clinical Activity of Sunitinib Malate as a Component of Neoadjuvant Therapy for Breast Cancer|
|Study Start Date :||April 2008|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||September 2010|
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.
- Change in Interstitial Fluid Pressure (IFP) Induced by Sunitinib Monotherapy [ Time Frame: baseline through end of segment 1 (2 weeks) ]Participants had their tumor IFP measured at baseline, after sunitinib monotherapy (segment 1) and after sunitinib+paclitaxel (segment 2). This outcome measure is the difference of the mean value from the end of segment 1 (sunitinib monotherapy) and the mean baseline value.
- Change in Interstitial Fluid Pressure (IFP) Induced by Paclitaxel Plus Sunitinib After Sunitinib Monotherapy [ Time Frame: end of cycle 1 (sunitinib monotherapy) to end of cycle 5 (paclitaxel/sunitinib therapy) (112 days) ]Participants had their tumor IFP measured at baseline, after sunitinib monotherapy (segment 1) and after sunitinib+paclitaxel (segment 2). This outcome measure is the difference of the mean value from the end of segment 2 (paclitaxel/sunitinib therapy through cycle 5) and end of segment 1 (sunitinib monotherapy) mean value.
- 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 ]
- To Evaluate the Safety of Paclitaxel Plus Sunitinib When Given in Combination as Neoadjuvant Therapy [ Time Frame: end of cycle 1 (sunitinib monotherapy) to end of cycle 5 (paclitaxel/sunitinib therapy) ]This measure determines the number of patients who had Grade 3/4 Adverse Events that were related to treatment while the patient was on paclitaxel plus sunitinib.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00656669
|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|