Ongoing Trials

• NSABP B-40 Prospective Breast Cancer: A Randomized Phase III Trial of Neoadjuvant Therapy in Patients with Palpable and Operable Breast Cancer Evaluating the Effect on Pathologic Complete Response (pCR) of Adding Capecitabine or Gemcitabine to Docetaxel when Administered Before AC with or without Bevacizumab and Correlative Science Studies Attempting to Identify Predictors of High Likelihood for pCR with Each of the Regimens.

              Partner: NSABP

     Completed Trials

• Breast Cancer Core Needle Biopsy Feasibility: Phase II Trial of 5-Fluorouracil, Epirubicin, Cyclophosphamide (FEC100) for 4 Cycles followed by Docetaxel with Capecitabine (wTX) with Herceptin (in HER2-positive patients only) Administered as Preoperative Therapy for Patients with Locally Advanced Breast Cancer, Stages II and III.

              Partner: US Oncology

• Feasibility of testing core needle breast biopsies ex vivo in the ChemoFx® assay: substudy results from US oncology trial 02-103. Holmes FA, Osborne C, Gallion H, Backner A, O'Shaughnessy J.. US Oncology Research, Inc, Houston, TX; Precision Therapeutics, Inc., Pittsburgh, PA

• MAMMOTOME® Study: A Technical Study to Determine the Assessability of Breast Biopsies obtained by the use of the MAMMOTOME® Device, for testing in the ChemoFx® Assay.

• Breast biopsies obtained with MAMMOTOME® device can be tested ex vivo with ChemoFx® assay. Beth B. Dupree, Alan Wells, Michael J. Gabrin, and Holly H. Gallion AACR Meeting Abstracts, Apr 2006; 2006: 1285.

• Core Biopsy Study: A Technical Study to Determine the Accessibility Rate of Core and fine needle aspiration Biopsies from Breast Cancer Tissue for Testing in the Precision Therapeutics, Inc. Chemoresponse Assay.

• Feasibility of testing core needle biopsies ex vivo in the ChemoFx assay. J. A. O'Shaughnessy, F. Holmes, P. Beitsch, J. Cunningham, H. Gallion, A. Backner, B. Hellerstedt, J. Pippen, S. Vukelja, B. Dupree Journal of Clinical Oncology, 2006 ASCO Annual Meeting Proceedings Part I. Vol 24, No. 18S (June 20 Supplement), 2006: 20073