Phase III Trial of Observation +/- Tamoxifen vs. RT +/- Tamoxifen for Good Risk Ductal Carcinoma In Situ (DCIS) of the Female Breast
Principal Investigator
Beryl McCormick, MD
Status
Terminated
Date Opened To Accrual
December 13 1999
Date Closed to Accrual
July 14 2006
Date of Study Termination
May 20 2022
Disease Site
Breast [BR]
Breast
Phase
III
Developmental Therapeutics
No
Primary Objective
In the defined good-risk group, assess the role of whole breast radiation plus/minus tamoxifen compared to wide excision to negative margins alone plus/minus tamoxifen, in decreasing or delaying the appearance of local failure, both invasive and in situ, and preventing the need for mastectomy.
Patient Population
Women >= 26 years of age. Unicentric mammographically detected DCIS. The DCIS must be detected by mammogram or detected as an "incidental" finding after a biopsy is performed for a benign histology (eg, fibroadenoma). Lesions <= 2.5 cm in greatest dimension on mammogram or pathologic specimen; use the largest measured size from the pathology report to obtain the required measurement of <= 2.5 cm. Lesions must be classified as low or intermediate grade DCIS. Inked margins >= 3 mm
Target Accrual
1790
Patient Study Webpage
There is no available patient study webpage available for this trial at this time.