NCT00003857
Radiation Therapy With or Without Optional Tamoxifen in Treating Women With Ductal Carcinoma in Situ
PHASE3
COMPLETED
NCT00003857
INTERVENTIONAL
Phase III Trial of Tamoxifen Alone vs. Tamoxifen Plus Radiation Therapy for Good Risk Duct Carcinoma In-Situ (DCIS) of the Female Breast
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.
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)
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age:
* 26 and over
Sex:
* Female
Menopausal status:
* Not specified
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* Not specified
Hepatic:
* Not specified
Renal:
* Not specified
Other:
* 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
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior chemotherapy
Endocrine therapy:
* No other concurrent hormonal therapy (e.g., raloxifene, hormone replacement therapy, or birth control pills)
Radiotherapy:
* No prior radiotherapy
Surgery:
* See Disease Characteristics
Breast Cancer
- TREATMENT
-
- Type: DRUG
- Name: tamoxifen citrate
- Description:
- Arm Group Labels: Observation +/- tamoxifen for 5 years, Radiation therapy +/- tamoxifen for 5 years
-
- Type: PROCEDURE
- Name: adjuvant therapy
- Description:
- Arm Group Labels: Observation +/- tamoxifen for 5 years, Radiation therapy +/- tamoxifen for 5 years
-
- Type: RADIATION
- Name: radiation therapy
- Description:
- Arm Group Labels: Radiation therapy +/- tamoxifen for 5 years
- Radiation Therapy Oncology Group