RTOG-9804

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

Status

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