Radiation Therapy With or Without Optional Tamoxifen in Treating Women With Ductal Carcinoma in Situ

December 01, 1999
132210
Cancer, Cancer - Breast
Grace Makari-Judson, MD
Baystate Breast and Wellness Center, 100 Wason Avenue, 3rd Floor, Springfield, MA
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor cells. It is not yet known if radiation therapy is more effective than observation, with or without tamoxifen, in treating ductal carcinoma in situ.

PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with that of observation, with or without tamoxifen, in treating women who have ductal carcinoma in situ.

Ages Eligible for Study: 26 Years to 120 Years (Adult, Older Adult)
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No

Disease Characteristics:
• Ductal carcinoma in situ (DCIS) of the breast detected by mammogram at the time of diagnosis
◦ Unicentric
◦ Lesions ≤ 2.5 cm
◦ Low nuclei grade (NG1) or intermediate nuclei grade (NG2) with necrosis in < one third of the involved ducts
◦ Inked margins ≥ 3 mm
◦ Clinically node negative
◦ Non-palpable
• No suspicious areas on post-operative mammogram taken within 12 weeks after final surgery
• No bloody nipple discharge
• No more than 12 weeks since prior final surgery (arm II only)

Exclusion Criteria:

• Not pregnant or nursing
• No active connective tissue disorders (e.g., lupus or scleroderma)
• No prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix

Active
Interventional (Clinical Trial), Randomized
3
Ruth Barham
413-794-3186