Clinical Research Details
Title:
A Randomized Phase II Trial of Weekly Nanoparticle Albumin-Bound Paclitaxel (Nab-Paclitaxel) (NSC-736631) With or Without Bevacizumab, Either Preceded by or Followed by Q 2 Week Doxorubicin (A) and Cyclophosphamide (C) Plus Pegfilgrastim (PEG-G) As Neoadjuvant Therapy for Inflammatory and Locally Advanced Her-2/Neu Negative Breast Cancer
Purpose:
The purposes of this study are to compare the pathologic complete response (pCR) rates in patients randomized to bevacizumab versus no bevacizumab, to compare the overall survival of patients randomized to the bevacizumab arm versus no bevacizumab and to explore molecular biomarkers related to biology and outcome of inflammatory breast cancer.
Study Number:
202217102109
Number of Patients:
200
Elgibility:
Participants must be women with a histologically or pathologically confirmed diagnosis of Her-2/NEU negative inflammatory or locally advanced breast carcinoma. Participants must not have had prior chemotherapy, radiation therapy or biologic therapy for invasive breast cancer within the past five years.
Treatment:
Participants will be assigned to one of three treatment groups.
Group 1 will receive bevacizumab every two weeks with abraxane weekly for 12 weeks. Then they will receive doxorubicin, cyclophosphamide and pegfilgastrim every two weeks for 12 weeks total.
Group 2 will receive abraxane every week for 12 weeks. Then they will receive doxorubicin, cyclophosphamide and pegfilgastrim every two weeks for 12 weeks.
Group 3 will receive doxorubicin, cyclophosphamide and pegfilgastrim every two weeks for 12 weeks. Then they will receive abraxane every week for 12 weeks.
Three to six weeks after chemotherapy treatment is completed, all participants (Groups 1, 2, 3) will have surgery to remove any remaining breast cancer tumor.
Principal Investigator:
Enrollment Phone:
(708) 327-2237