Stages II-III Breast Cancer Clinical Trial
Official title:
Phase I Study of Neoadjuvant Chemotherapy With Nanoparticle Albumin Bound Paclitaxel, Doxorubicin and Cyclophosphamide (NAC) in Patients With Stages II-III Breast Cancer
The purpose of this clinical trial is to test whether treatment of patients with breast cancer with the combination of Abraxane (nab-paclitaxel), Adriamycin (doxorubicin), and Cyclophosphamide prior to surgery is safe and results in good tumor response. Up to 24 patients may be enrolled in this study at the Mitchell Cancer Institute. All patients enrolling in this study will receive treatment with the combination of Abraxane, Adriamycin, and Cyclophosphamide.
This is a single center, open phase I dose escalation study with expansion cohort. The dose
escalation part of the study is now closed and the highest tolerable dose of nab-paclitaxel
(Abraxane) was assessed to be 100 mg/m2 in combination with doxorubicin (Adriamycin) and
cyclophosphamide in patients with stages II-III breast cancer in the neoadjuvant setting.
The initial phase I study objective was to primarily assess the safety of the drug
combination, and to secondarily obtain preliminary data on the clinical efficacy of the
combination. 25 patients were enrolled. The expansion cohort will enroll 15 additional
patients.
The purpose of the expansion cohort is to assess pathological complete response.
;