Clinical trial · Interventional
Adjuvant Radiation Therapy Compared With Observation After Surgery in Treating Women With Estrogen Receptor Positive or Progesterone Receptor Positive Ductal Carcinoma In Situ of the Breast Who Are Receiving Tamoxifen or Anastrozole
Randomised Trial Testing Observation (No Radiotherapy) Against Radiotherapy In Women With Low-Risk Completely Excised ER Positive Ductal Carcinoma In Situ (DCIS) Of The Breast On Adjuvant Endocrine Therapy
- 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. It is not yet known whether radiation therapy after surgery is effective in preventing a recurrence of ductal carcinoma in situ. PURPOSE: This randomized phase II trial is studying adjuvant radiation therapy to see how well it works compared to observation after surgery in treating women with estrogen receptor positive or progesterone receptor positive ductal carcinoma in situ and are also receiving either tamoxifen or anastrozole.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| anastrozole | Drug | Anastrozole | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
| tamoxifen citrate | Drug | Tamoxifen | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Local tumor control (invasive and in situ local recurrence)
Secondary outcomes (7)
- measure
- Mastectomy rate
- measure
- Pattern of relapse in the breast
- measure
- Contralateral primary
- measure
- Breast cancer metastases
- measure
- Mortality
- measure
- Quality of life
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
- Maximum age
- 70 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Diagnosis of unifocal ductal carcinoma in situ of the breast without an invasive component * Microinvasion (defined as 1 or more foci of invasion each \< 1 mm) allowed * Prior complete microscopic excision (within the past 6 months) with a minimum radial margin of 1 mm by specimen x-ray required * Maximum microscopic tumor diameter \< 30 mm (\< 15 mm if grade 3 tumor) * Planning to receive adjuvant tamoxifen or anastrozole for 5 years * Eligible patients may receive adjuvant endocrine therapy on ICR-IBIS-II * Hormone receptor status: * Estrogen receptor positive OR * Progesterone receptor positive * More than 10% tumor staining for receptor OR a cutpoint of ≥ 2 PATIENT CHARACTERISTICS: Sex * Female Menopausal status * Premenopausal, perimenopausal, or postmenopausal Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Cardiovascular * No prior deep vein thrombosis Pulmonary * No prior pulmonary embolus Other * No unexplained postmenopausal bleeding * No contraindication to full-dose radiotherapy to the breast * No other cancer within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * See Disease Characteristics * No prior tamoxifen or raloxifene use for more than 3 months in duration Radiotherapy * Not specified Surgery * See Disease Characteristics * No prior mastectomy Other * No concurrent anticoagulants
References
Publications (0)
Data not yet available