The purpose of this study is to identify new treatment regimens with better response rates and to find out if the combination of cisplatin and sorafenib followed by paclitaxel and sorafenib can shrink the size of your breast tumor and allow you to preserve your breast. Sorafenib is a newer drug that targets blood vessel formation and may help the chemotherapy work better. Additionally, by receiving chemotherapy before surgery, we will be able to determine if your cancer is responsive to chemotherapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Sorafenib 400 mg twice daily throughout the study. Patients will receive this as a single-agent for the first four weeks, then in combination with cisplatin followed by paclitaxel.
75 mg/m² given IV
175 mg/m² given IV
Grady Memorial Hospital
Atlanta, Georgia, United States
Emory University Hospital Midtown
Atlanta, Georgia, United States
Emory University Winship Cancer Institute
Atlanta, Georgia, United States
Pathologic Complete Response (pCR) at the Time of Surgery After Preoperative Treatment
Pathologic complete response (pCR): Absence of invasive breast cancer in the breast (mastectomy or lumpectomy) specimen at the time of definitive surgery. Presence of in situ cancer alone will be considered a pCR but may be recorded separately.
Time frame: At the time of surgery, after 24 weeks of preoperative treatment
Clinical Response Rate During Follow-up (Disease Recurrence)
Response will be assessed according to World Health Organization criteria with progressive disease (PD) defined as a 25% or greater increase in a single lesion, OR reappearance of any lesion which has disappeared, OR clear worsening of any evaluable disease OR appearance of any new lesion/site.
Time frame: Up to 2 years after definitive surgery
Clinical Response Rate (Complete Pathologic Response Rate After Surgery)
Pathologic complete response (pCR): Absence of invasive breast cancer in the breast (mastectomy or lumpectomy) specimen during follow-up. Presence of in situ cancer alone will be considered a pCR but may be recorded separately.
Time frame: Up to 2 years after definitive surgery
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