National Surgical Adjuvant Breast and Bowel Project

WHAT ARE CLINICAL TRIALS AND WHY ARE THEY IMPORTANT?

Federally-Supported Clinical Trials

Open NSABP Clinical Trials

Protocol B-36

Protocol B-37

Protocol B-39

Protocol B-40

Protocol B-42

Protocol C-10

Protocol R-04

Industrial-Supported Clinical Trials

NSABP Oncology Therapeutic Research Program (OTRP) - Phase III Studies

Open NSABP OTRP Clinical Trials

Protocol B-41

In 2002, realizing the need toave experience with new pharmaceuticals earlier in their development, the NSABP established the Foundation Research Program (FRP), in which Phase II studies totally supported by industry are carried out. This was done primarily to allow the NSABP to test agents in the Phase II setting and be able to move them directly into our large Phase III program, which is supported by the NCI.

We have completed the pilot program and have published the results of the first Phase II studies. In Summer 2004, we made the commitment to broaden the FRP and now have employees devoted solely to the Phase II program and its expansion and development.

Open NSABP FRP Clinical Trials

Protocol FB-4

Protocol FB-5

NSABP Tissue Bank

For more than 35 years, as part of all NSABP Phase III studies, tissue has been collected from participating patients. The result is a tissue bank housing specimens from more than 65,000 patients for whom clinical follow-up data is available. These data link the tumor with the results of the treatment, making the NSABP Tissue Bank a unique research resource. The tissue bank, with its archival tumor specimens and extensive NSABP clinical data base, has been deemed a “national treasure” by the NCI.

The NSABP researchers based in Pittsburgh have utilized the specimens in conjunction with industry to evaluate molecular markers in a series of studies that has been aimed at defining prognosis and response to chemotherapy in patients who have participated in our studies. The Oncotype DX was our first collaborative effort which has now produced a laboratory test that is commercially available throughout the United States. We see this as an opportunity for future advances in both breast and colon cancer.

The NSABP is the steward of the tissue bank and sees as part of our responsibility the sharing of tissue bank specimens with others both in academia and in industry, along with providing access to the related clinical data. To that end, we have established a formal procedure for requesting tissue from the bank. In addition to the NSABP’s own research activities, other investigators in the broad general scientific community, have met the established qualifications and have received approval for the use of NSABP tissue. We are the first national clinical trials group to have established such a program.

NSABP Division of Pathology Contacts and Information

NSABP Pathology Laboratory Grand Opening (October 2006)

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