National Surgical Adjuvant Breast and Bowel Project

WHAT ARE CLINICAL TRIALS AND WHY ARE THEY IMPORTANT?

Federally Supported Clinical Trials

Clinical Trials Open To Accrual

Breast

    Protocol B-37 (anticipate closure to accrual in January 2010)

    Protocol B-39

    Protocol B-40

    Protocol B-43

Colorectal

    Protocol C-11 (anticipate activation before mid-2010)

    Protocol R-04

Industry Supported Clinical Trials

In 2002, realizing the need to have experience with new pharmaceutical agents earlier in their development cycle, 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 Phase III program. Since completing the FRP pilot program, we have published the results of the first several Phase II studies.

In 2007, NSABP made the commitment to broaden the industry supported trials conducted by NSABP to include Phase III studies. The Division of Industry Trials, with employees dedicated solely to industry supported studies, includes these Phase III studies and the Phase II studies conducted under the FRP.

Phase III Industry Trials Open To Accrual

Breast Cancer

    Protocol B-41

    Protocol B-44-I

    Protocol B-46-I

Colon Cancer

    VELOUR Trial

Phase II FRP Industry Trials Open To Accrual

Breast Cancer

    Protocol FB-6

Colon Cancer

    Protocol FC-4

    Protocol FC-6 (anticipate activation early in 2010)

Division of Pathology & NSABP Biospecimen Bank

NSABP Biospecimen Bank

For more than 35 years, as part of all NSABP Phase III studies, biospecimens have been collected from patients participating in those NSABP clinical trials. The result is a repository housing biospecimens from more than 90,000 patients for whom clinical follow-up data is available. This data links the biospecimen with the results of the treatment, making the NSABP Biospecimen Bank a unique research resource. The Biospecimen 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 and academic investigators to evaluate molecular markers in a series of studies that has been aimed at defining prognosis and response to chemotherapy and interesting agents in patients who have participated in our studies. Our first collaborative effort resulted in a laboratory test, called Oncotype DX, which has been commercially available throughout the world. We see the utilization of this valuable biospecimen bank resource as an opportunity for future advances in both breast and colon cancer.

The NSABP is the steward of the biospecimen repositories and sees as part of its responsibility the sharing of biospecimens 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 biospecimen resources from the banks. In addition to the NSABP’s own research activities, other investigators in the broad scientific community have met the established qualifications and have received approval for the use of NSABP biospecimens. We are the first national clinical trials group to have established such an open access program.

NSABP Division of Pathology Contacts and Information

NSABP Pathology Laboratory Grand Opening (October 2006)