Phase II Study of Neoadjuvant Treatment With NOV-002 in Combination With Doxorubicin and Cyclophosphamide Followed by Docetaxel in Patients With Stages IIB-IIIC Breast Cancer
- The primary objective of this study is to define the rate of pathologic complete
response rate (pCR) in the affected breast after the preoperative administration of
NOV-002 in combination with doxorubicin and cyclophosphamide followed by docetaxel in
patients with stage IIB-IIIC breast cancer.
- Define the safety profiles of preoperative administration of NOV-002 in combination
with doxorubicin hydrochloride and cyclophosphamide followed by docetaxel.
- Correlate serum protein glutathionylation with clinical and pathologic responses.
OUTLINE: This is a multicenter study.
Patients receive oxidized glutathione (NOV-002) IV twice on day -1 of course 1 and once on
day 1 of courses 2-8. Patients receive NOV-002 subcutaneously once daily on days 2-21 of
courses 1-8. Patients also receive chemotherapy comprising doxorubicin hydrochloride IV and
cyclophosphamide IV on day 1 of courses 1-4 followed by docetaxel IV on day 1 of courses
5-8. Treatment repeats every 21 days in the absence of disease progression or unacceptable
Patients undergo definitive surgery 3-6 weeks after completion of neoadjuvant therapy.
Blood samples are obtained at baseline and periodically during study to measure serum and
plasma protein glutathionlylation. Additional blood samples are collected from some patients
for immunological correlative studies.
After completion of study therapy, patients are followed at 30 days.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Percentage of Participants Achieving Pathologic Complete Response
Pathologic complete response (pCR) is defined according to Hankoop et al  as either: the absence of any histological evidence of invasive breast cancer cells in the tissue specimen removed from the breast or the presence of invasive tumor equal to or less than 10mm after preoperative treatment, determined at definitive breast surgery.
Keisuke Shirai, MD
Medical University of South Carolina
United States: Food and Drug Administration
|Hollings Cancer Center at Medical University of South Carolina||Charleston, South Carolina 29425|
|University of Miami Sylvester Comprehensive Cancer Center - Miami||Miami, Florida 33136|