Description:
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.
Title
- Brief Title: Radiation Therapy With or Without Optional Tamoxifen in Treating Women With Ductal Carcinoma in Situ
- Official Title: Phase III Trial of Tamoxifen Alone vs. Tamoxifen Plus Radiation Therapy for Good Risk Duct Carcinoma In-Situ (DCIS) of the Female Breast
Clinical Trial IDs
- ORG STUDY ID:
RTOG-9804
- SECONDARY ID:
CDR0000067020
- SECONDARY ID:
CAN-NCIC-MA26
- SECONDARY ID:
CALGB-49801
- SECONDARY ID:
NCI-2011-02038
- NCT ID:
NCT00003857
Conditions
Interventions
Drug | Synonyms | Arms |
---|
tamoxifen citrate | | Observation +/- tamoxifen for 5 years |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Observation +/- tamoxifen for 5 years | Active Comparator | Observation +/- tamoxifen 20 mg per day for 5 years | |
Radiation therapy +/- tamoxifen for 5 years | Experimental | Radiation therapy to the whole breast +/- tamoxifen 20 mg per day for 5 years | |
Eligibility 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
Maximum Eligible Age: | 120 Years |
Minimum Eligible Age: | 26 Years |
Eligible Gender: | Female |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Local recurrence (e.g., invasive or noninvasive recurrence) |
Time Frame: | 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. |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Overall survival |
Time Frame: | From randomization to date of death or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. |
Safety Issue: | |
Description: | |
Measure: | Time to distant metastasis |
Time Frame: | From randomization to date of distant metastasis or last follow-up. Analysis occurs after all patients have been potentially followed for 5 years. |
Safety Issue: | |
Description: | |
Measure: | Invasive local recurrence |
Time Frame: | 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. |
Safety Issue: | |
Description: | |
Measure: | Salvage mastectomy rate |
Time Frame: | Analysis occurs after all patients have been potentially followed for 5 years. |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Radiation Therapy Oncology Group |
Trial Keywords
- breast cancer in situ
- ductal breast carcinoma in situ
Last Updated
October 19, 2020