Clinical trial · Interventional
Radiation Therapy With or Without Optional Tamoxifen in Treating Women With Ductal Carcinoma in Situ
Phase III Trial of Tamoxifen Alone vs. Tamoxifen Plus Radiation Therapy for Good Risk Duct Carcinoma In-Situ (DCIS) of the Female Breast
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| radiation therapy | Radiation | — | UNRESOLVED |
| tamoxifen citrate | Drug | Tamoxifen | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Observation +/- tamoxifen for 5 years
- description
- Observation +/- tamoxifen 20 mg per day for 5 years
- interventionNames
- Drug: tamoxifen citrate
- Procedure: adjuvant therapy
- type
- EXPERIMENTAL
- label
- Radiation therapy +/- tamoxifen for 5 years
- description
- Radiation therapy to the whole breast +/- tamoxifen 20 mg per day for 5 years
- interventionNames
- Drug: tamoxifen citrate
- Procedure: adjuvant therapy
- Radiation: radiation therapy
Primary outcomes (1)
- measure
- Local recurrence (e.g., invasive or noninvasive recurrence)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 26 Years
- Maximum age
- 120 Years
Show eligibility criteria text
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
References
Publications (2)
- RESULTMcCormick B, Winter K, Hudis C, Kuerer HM, Rakovitch E, Smith BL, Sneige N, Moughan J, Shah A, Germain I, Hartford AC, Rashtian A, Walker EM, Yuen A, Strom EA, Wilcox JL, Vallow LA, Small W Jr, Pu AT, Kerlin K, White J. RTOG 9804: a prospective randomized trial for good-risk ductal carcinoma in situ comparing radiotherapy with observation. J Clin Oncol. 2015 Mar 1;33(7):709-15. doi: 10.1200/JCO.2014.57.9029. Epub 2015 Jan 20. PMID 25605856
- DERIVEDMcCormick B, Winter KA, Woodward W, Kuerer HM, Sneige N, Rakovitch E, Smith BL, Germain I, Hartford AC, O'Rourke MA, Walker EM, Strom EA, Hopkins JO, Pierce LJ, Pu AT, Sumida KNM, Vesprini D, Moughan J, White JR. Randomized Phase III Trial Evaluating Radiation Following Surgical Excision for Good-Risk Ductal Carcinoma In Situ: Long-Term Report From NRG Oncology/RTOG 9804. J Clin Oncol. 2021 Nov 10;39(32):3574-3582. doi: 10.1200/JCO.21.01083. Epub 2021 Aug 18. PMID 34406870