Comparing Treatment for Women with DCIS
Name of the Trial
Phase III Randomized Study of Anastrazole Versus Tamoxifen in Postmenopausal Women with Ductal Carcinoma in Situ of the Breast Undergoing Lumpectomy and Radiotherapy (NSABP-B-35). See the protocol abstract at http://cancer.gov/clinicaltrials/NSABP-B-35.
Dr. Richard Margolese, National Surgical Adjuvant Breast and Bowel Project; Dr. Betty Mincey, North Central Cancer Treatment Group; Dr. Kathy Albain, Southwest Oncology Group; Dr. Pat W. Whitworth, American College of Surgeons Oncology Group.
Why Is This Trial Important?
Ductal carcinoma in situ (DCIS) of the breast is a noninvasive condition in which a small mass of cells has formed within a milk duct but has not spread outside the duct. Some but not all DCIS will become invasive breast cancer. Breast-conserving surgery (lumpectomy) combined with radiation therapy and total mastectomy are standard treatments for DCIS. Post-surgical treatment with the drug tamoxifen may further reduce the chance of DCIS recurrence or invasive breast cancer development.
Recent studies indicate that anastrazole, which belongs to a class of drugs called aromatase inhibitors, is more effective than tamoxifen in preventing breast cancer recurrence in postmenopausal women treated with surgery for invasive breast cancer. In this trial, researchers are investigating whether anastrazole is more effective than tamoxifen in preventing DCIS recurrence and invasive breast cancer development in postmenopausal women treated with lumpectomy and radiation therapy for DCIS.
"Anastrazole has shown significant improvements over tamoxifen in terms of safety and efficacy," said Dr. Margolese. "We believe it has the potential to be an important treatment option for women with DCIS."
Who Can Join This Trial?
Researchers seek to enroll 3,000 postmenopausal women with a confirmed diagnosis of DCIS who have had their tumors surgically removed. See the list of eligibility criteria at http://cancer.gov/clinicaltrials/NSABP-B-35.
Where Is This Trial Taking Place?
Multiple study sites in the United States and Canada are recruiting patients for this trial. See the list of study sites at http://cancer.gov/clinicaltrials/NSABP-B-35.
See the list of study contacts at http://cancer.gov/clinicaltrials/NSABP-B-35 or call the NCI’s Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). The call is toll free and completely confidential.
An archive of "Featured Clinical Trial" columns is available at http://cancer.gov/clinicaltrials/ft-all-featured-trials.