A Phase II Study Evaluating the Safety and Efficacy of Sunitinib Maleate in Combination With Weekly Paclitaxel Followed by Doxorubicin and Daily Oral Cyclophosphamide Plus G-CSF as Neoadjuvant Chemotherapy for Locally Advanced or Inflammatory Breast Cancer
I.To assess the microscopic pathologic complete response rate (pCR) in patients treated with
a two part, neoadjuvant regimen consisting of daily oral sunitinib with weekly IV paclitaxel
for 12 weeks followed by weekly doxorubicin and daily oral cyclophosphamide given with
filgrastim (G-CSF) support for 15 weeks.
I. To assess the association between microscopic pCR and clinical complete response rate at
the primary tumor site.
II. To assess the relapse rate, overall and disease-free survival in patients with breast
cancer treated with neoadjuvant chemotherapy consisting of daily oral sunitinib with weekly
IV paclitaxel for 12 weeks followed weekly doxorubicin and daily oral cyclophosphamide given
with G-CSF support for 15 weeks.
III. To assess the toxicity associated with these regimens. IV. To explore the relationship
between planned correlative laboratory and clinical studies and indicators of efficacy such
as pathologic response, clinical response and relapse.
Patients receive neoadjuvant chemotherapy comprising sunitinib malate orally (PO) once daily
and paclitaxel intravenously (IV) over 1 hour once weekly for 8-12 weeks in the absence of
disease progression or unacceptable toxicity. Beginning within 3 weeks of completion of
sunitinib malate and paclitaxel, patients receive doxorubicin IV once weekly for 15 weeks,
cyclophosphamide PO once daily for 15 weeks, and filgrastim subcutaneously (SC) on days 2-7
for 16 weeks in the absence of disease progression or unacceptable toxicity. Beginning 3-6
weeks after completion of chemotherapy, patients undergo surgery.
After completion of study treatment, patients are followed up every 3 months for 2 years,
every 6 months for 3 years, and then annually thereafter.
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Microscopic pathologic CR (pCR) rate
Defined as no evidence of microscopic invasive tumor present at primary tumor site in the surgical specimen and calculated with exact 90% binomial confidence interval.
At the time of surgery
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Institutional Review Board
|Arizona Cancer Center||Tucson, Arizona 85724|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|
|Olympic Medical Center||Port Angeles, Washington 98362|
|Katmai Oncology Group||Anchorage, Alaska 99508-4627|
|Anchorage Oncology Centre||Anchorage, Alaska 99508|
|Saint Luke's Mountain States Tumor Institute||Boise, Idaho 83712|
|Skagit Valley Hospital||Mt. Vernon, Washington 98273|