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

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: Primary Compare ipsilateral tumor relapse and breast cancer metastases in women with completely excised low-risk estrogen receptor- or progesterone receptor-positive ductal carcinoma in situ of the breast receiving adjuvant tamoxifen or anastrozole and treated with adjuvant radiotherapy vs observation alone. Compare the quality of life of patients treated with these regimens. Secondary Determine the minimal surgical margins required to minimize the local recurrence rate in patients treated with these regimens. Identify molecular markers that predict ipsilateral tumor recurrence in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms. All patients receive adjuvant tamoxifen or anastrozole for 5 years. Arm I: Patients undergo radiotherapy 5 days a week for 3 or 5 weeks. Arm II: Patients undergo observation alone. Quality of life is assessed at baseline, at 6 months, and then at 1, 2, and 5 years. Patients are followed every 6 months for 1 year and then annually for up to 10 years. Peer Reviewed and Funded or Endorsed by Cancer Research UK PROJECTED ACCRUAL: A total of 2,000 patients (1,000 per treatment arm) will be accrued for this study within 5 years.

Official Title
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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

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: anastrozole
* Drug: tamoxifen citrate
* Procedure: adjuvant therapy
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: anastrozole|nan|
|Drug: tamoxifen citrate|nan|
|Procedure: adjuvant therapy|nan|
|Radiation: radiation therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local tumor control (invasive and in situ local recurrence) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mastectomy rate |  |  | 
| Pattern of relapse in the breast |  |  | 
| Contralateral primary |  |  | 
| Breast cancer metastases |  |  | 
| Mortality |  |  | 
| Quality of life |  |  | 
| Molecular markers that predict ipsilateral tumor recurrence |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ductal breast carcinoma in situ, breast cancer in situ