Breast Cancer
Conditions
Keywords
breast cancer in situ, ductal breast carcinoma in situ
Brief summary
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.
Detailed description
OBJECTIVES: * Compare the efficacy of whole breast radiotherapy vs observation with or without optional tamoxifen in decreasing or delaying the appearance of local failure (both invasive and in situ) and preventing the need for mastectomy in women with good-risk ductal carcinoma in situ (DCIS) of the breast. * Compare distant disease-free survival of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (under 50 vs 50 and over), final path margins (negative vs 3-9 mm vs at least 10 mm), mammographic size of primary (no greater than 1 cm vs greater than 1 cm to 2.5 cm), nuclei grade (low vs intermediate), and tamoxifen use (yes vs no). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients undergo observation and may receive optional oral tamoxifen once daily (at the discretion of the physician) for 5 years. * Arm II: Beginning within 12 weeks after final surgery, patients receive radiotherapy to the whole breast once daily, 5 days a week, for 3.5-5.5 weeks. Patients may receive optional tamoxifen as in arm I. Patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 1,790 patients will be accrued for this study within 6 years.
Interventions
DRUGtamoxifen citrate
PROCEDUREadjuvant therapy
RADIATIONradiation therapy
Sponsors
National Cancer Institute (NCI)
Cancer and Leukemia Group B
NCIC Clinical Trials Group
NRG Oncology
Radiation Therapy Oncology Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
26 Years to 120 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Local recurrence (e.g., invasive or noninvasive recurrence) | From randomization to date of local failure in the treated breast or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival | From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. |
| Time to distant metastasis | From randomization to date of distant metastasis or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. |
| Invasive local recurrence | From randomization to date of invasive local failure in the treated breast or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. |
| Salvage mastectomy rate | Analysis occurs after all patients have been potentially followed for 5 years. |
Countries
Canada, United States
Outcome results
None listed