This trial will examine the combination of sunitinib plus paclitaxel and carboplatin as neoadjuvant treatment for locally advanced breast cancer.
This open label, Phase I/II trial is designed to evaluate the combination of sunitinib plus paclitaxel and carboplatin as neoadjuvant treatment for locally advanced breast cancer. The Phase I portion of this study will determine the maximum tolerated dose (MTD) of paclitaxel, sunitinib and carboplatin that can be used together as neoadjuvant treatment in patients with locally advanced breast cancer. The MTD identified in the Phase I portion of the study will be used in the Phase II portion which will evaluate the efficacy, safety, and tolerability of neoadjuvant sunitinib/paclitaxel/carboplatin given for 6 cycles in patients with locally advanced breast cancer.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
IV infusion per institutional guidelines on Days 1, 8 and 15 of a 28 day cycle as follows depending on dose level (DL): DL1- 70 mg/m2, DL2- 80 mg/m2, DL3- 80mg/m2, DL4- 80mg/m2, DL-1- 70mg/m2, DL-2- 60mg/m2
IV infusion per institutional guidelines Day 1 of a 28 day cycle as follows depending on dose level (DL): DL1- AUC=5, DL2- AUC=5, DL3- AUC=6, DL4- AUC=6, DL-1- AUC=4, DL-2- AUC=4
By mouth (PO) once daily on days 1-21 of a 28 day cycle as follows depending on dose level (DL): DL1- 25mg, DL2-25mg, DL3- 25mg, DL4- 37.5mg, DL-1- 25mg, DL-2- 25mg. Maintenance therapy of 25mg daily
Holy Cross Hospital
Fort Lauderdale, Florida, United States
Florida Cancer Specialists North
Fort Myers, Florida, United States
Florida Cancer Specialists South
Phase II: The Number of Subjects Exhibiting Pathologic Complete Response to Neoadjuvant Treatment With Sunitinib/Paclitaxel/Carboplatin
Pathologic complete response (PCR) is defined as no residual invasive breast cancer in final breast or axillary lymph node samples.
Time frame: at weeks 26-30
Number of Participants With Adverse Events as a Measure of Safety and Tolerability
Assessments will be made through analysis of reported incidence of treatment-emergent adverse events (AEs) and serious adverse events (SAEs) at the phase II dose
Time frame: Days 1, 8, and 15 of each 4-week cycle up to 24 weeks during neoadjuvant treatment, and every 4 weeks during maintenance treatment
Overall Response Rate (ORR)
Assessed by clinical, radiologic and surgical determinations before and after neoadjuvant therapy. Measurable lesions will be defined by RECIST criteria v1.1.
Time frame: Days 1, 8 and 15 of each cycle, minimum of 12 weeks
Disease-free Survival
Defined as the time between day of surgery to first documented disease occurrence or death due to any cause.
Time frame: every 4 weeks from date of surgery until treatment discontinuation or death, expected average 18 months
Overall Survival (OS)
Defined as the time between Day 1 Cycle 1 to time of death from any cause.
Time frame: 24 months
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Fort Myers, Florida, United States
Northeast Georgia Medical Center
Gainesville, Georgia, United States
Providence Medical Group
Terre Haute, Indiana, United States
Baptist Hospital East
Louisville, Kentucky, United States
Center for Cancer and Blood Disorders
Bethesda, Maryland, United States
National Capital Clinical Research Consortium
Bethesda, Maryland, United States
St. Louis Cancer Care
Chesterfield, Missouri, United States
Nebraska Methodist Cancer Center
Omaha, Nebraska, United States
...and 4 more locations