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Current NSABP Breast Cancer Trials

Current NSABP Breast Cancer Trials
Richard Kaderman, Ph.D.

Profile of the NSABP

History:

The National Surgical Adjuvant Breast and Bowel Project (NSABP) is a cooperative group that was formally established in 1971 to conduct clinical trials in breast and colorectal cancer research; however, members have been involved in collaborative research since 1958.

Over 50,000 women and men have been enrolled in NSABP clinical treatment trials. In the Breast Cancer Prevention Trial, over 100,000 women were screened and 13,388 were enrolled.

Organization:

  • NSABP Operations Center: Norman Wolmark, MD, Principal Investigator East Commons Professional Bldg. Four Allegheny Center - 5th Floor Pittsburgh, PA 15212-5234 Phone: (412) 330-4600 Fax: (412) 330-4660

  • NSABP Biostatistical Center: Dr. H. Samuel Wieand, Director University of Pittsburgh One Sterling Plaza 201 North Craig Street, Suite 500 Pittsburgh, PA 15213 Phone: (412) 624-2666 Fax: (412) 624-1082

 

Bernard Fisher, MD, Scientific Director, NSABP

NSABP group photo, circa early 1980's

Membership:

Members include 300 medical centers in the United States, Canada and Australia, and over 6000 physicians, nurses and other medical professionals in the NSABP member institutions and their satellites. Institutions include major medical centers, university hospitals, large oncology practice groups and health maintenance organizations.

Funding:

The National Cancer Institute (NCI) is the primary source of funding for NSABP clinical trials and the Operations and Biostatistical Centers. Other sources fund ancillary studies, training and educational programs.

Impact of Select NSABP Clinical Trials on Breast Cancer Management

Emergence of breast-conserving surgery as standard of care. These findings contributed to the 1990 NIH consensus conference recommendation that lumpectomy and breast irradiation be the preferred procedure for women with primary breast cancer.

Fisher B, Anderson S, Redmond C, et al. Reanalysis and Results after 12 Years of Follow-up in a Randomized Clinical Trial Comparing Total Mastectomy with Lumpectomy with or without Irradiation in the Treatment of Breast Cancer. New England Journal of Medicine 333:22:1456-1461, 1995.

First demonstration that systemic therapy could alter the natural history of primary breast cancer.

Fisher B, Redmond C, Brown A, et al. Treatment of Primary Breast Cancer with Chemotherapy and Tamoxifen. New England Journal of Medicine 305:1-6, 1981.
The benefits of adjuvant tamoxifen for women with invasive and noninvasive breast cancer.

Fisher B, Costantino J, Redmond C, et al. A Randomized Clinical Trial Evaluating Tamoxifen in the Treatment of Patients with Node-Negative Breast Cancer Who Have Estrogen Receptor-Positive Tumors. New England Journal of Medicine 320:479-484, 1989.

Fisher B, Dignam J, Wolmark N, et al. Tamoxifen in treatment of intraductal breast cancer: National Surgical Adjuvant Breast and Bowel Project B-24 randomised controlled trial. Lancet 353(9169):1993-2000, June 12, 1999.

Fisher B, Dignam J, Bryant J, et al. Five Versus More Than Five Years of Tamoxifen Therapy for Breast Cancer Patients with Negative Lymph Nodes and Estrogen Receptor-Positive Tumors. Journal of the National Cancer Institute 88:1529-42, 1996.

First demonstration of improved disease-free and overall survival due to adjuvant therapy in node-negative breast cancer patients, including women with very small tumors.

Fisher B, Dignam J, Tan-Chiu E, et al. Prognosis and Treatment of Patients With Breast Tumors of One Centimeter or Less and Negative Axillary Lymph Nodes Journal of the National Cancer Institute 93: 112-120, 2001

Fisher B, Dignam J, Mamounas EP, et al. Sequential Methotrexate 5-Fluorouracil (M_F) for the Treatment of Node-Negative Breast Cancer Patients with Estrogen Receptor-Negative Tumors: Eight-Year Results from NSABP B-13 and First Report of Findings from NSABP B-19 Comparing M_F with Conventional CMF. Journal of Clinical Oncology 14:7:1982-1992, 1996.

Fisher B, Dignam J, Wolmark N, et al. Tamoxifen and Chemotherapy for Lymph Node-Negative, Estrogen Receptor-Positive Breast Cancer. Journal of the National Cancer Institute 89.22:1673-1682, 1997.
Fisher B, Dignam J, Wolmark N, et al. Tamoxifen and Chemotherapy for Lymph Node-Negative, Estrogen Receptor-Positive Breast Cancer. Journal of the National Cancer Institute 89.22:1673-1682, 1997.

Combination chemohormonal therapies improve disease-free and overall survival in node-negative, receptor-positive breast cancer patients.

 

Fisher B, Dignam J, Wolmark N, et al. Tamoxifen and Chemotherapy for Lymph Node-Negative, Estrogen Receptor-Positive Breast Cancer. Journal of the National Cancer Institute 89.22:1673-1682, 1997.

Preoperative chemotherapy results in significant downstaging in axillary nodal status (80% response rate) and an increase in breast-conserving treatment, with improved disease-free and overall survival in patients who achieved a complete pathological response.

Fisher B, Bryant J, Wolmark N, et al. Effect of Preoperative Chemotherapy on the Outcome of Women with Operable Breast Cancer. Journal of Clinical Oncology 16(8):2672-2685, 1998.

Tamoxifen reduces the risk of developing breast cancer by 50% or more in high-risk women, prompting the FDA to grant approval for the drug as the first chemopreventive agent for breast cancer.

Fisher B, Costantino JP, Wickerham DL, et al. Tamoxifen for prevention of breast cancer: report of the National Surgical Adjuvant Breast and Bowel Project P-1 Study. Journal of the National Cancer Institute 90:18:1371-1388, 1998.

Current NSABP Breast Cancer Trials

For additional information visit the NSABP website at http://www.nsabp.pitt.edu/

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