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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
sunitinib alone (segment 1): During the first segment, patients will receive single-agent sunitinib for 2 weeks.
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 cyclophosphamide (Segment 3): Following Segment 2, patients will receive 4 cycles (8 weeks) of neoadjuvant treatment with AC.
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
Change in Interstitial Fluid Pressure (IFP) Induced by Sunitinib Monotherapy
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.
Time frame: baseline through end of segment 1 (2 weeks)
Change in Interstitial Fluid Pressure (IFP) Induced by Paclitaxel Plus Sunitinib After Sunitinib Monotherapy
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.
Time frame: end of cycle 1 (sunitinib monotherapy) to end of cycle 5 (paclitaxel/sunitinib therapy) (112 days)
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
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.
Time frame: end of cycle 1 (sunitinib monotherapy) to end of cycle 5 (paclitaxel/sunitinib therapy)
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