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: Randomized phase II trial to compare the effectiveness of adjuvant radiation therapy with that of observation after surgery in treating women who have estrogen receptor positive or progesterone receptor positive ductal carcinoma in situ and are also receiving either tamoxifen or anastrozole.

Condition	Treatment or Intervention	Phase
intraductal breast carcinoma breast cancer in situ	Drug: anastrozole  Drug: tamoxifen  Procedure: adjuvant therapy  Procedure: antiestrogen therapy  Procedure: aromatase inhibition  Procedure: endocrine therapy  Procedure: hormone therapy  Procedure: radiation therapy	Phase II

Further Study Details: 

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.

PROJECTED ACCRUAL: A total of 2,000 patients (1,000 per treatment arm) will be accrued for this study within 5 years.

Ages Eligible for Study:  50 Years   -   75 Years,  Genders Eligible for Study:  Both

Criteria

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 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: Age

• 50 to 75

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

United Kingdom, England
      Institute of Cancer Research - UK, Sutton,  England,  SM2 5NG,  United Kingdom; Recruiting
      Royal Marsden NHS Foundation Trust - Surrey, Sutton,  England,  SM2 5PT,  United Kingdom; Recruiting
      South Manchester University Hospital, Manchester,  England,  M23 9LT,  United Kingdom; Recruiting
United Kingdom, Scotland
      Ninewells Hospital and Medical School, Dundee,  Scotland,  DD1 9SY,  United Kingdom; Recruiting
      University of Glasgow, Glasgow,  Scotland,  G11 6NT,  United Kingdom; Recruiting

Study chairs or principal investigators

Judith Bliss,  National Cancer Research Institute (NCRI)   

Study ID Numbers:  CDR0000349580; ICR-DCIS-II; EU-20341; NCT00077168
Record last reviewed:  April 2004
Last Updated:  December 6, 2004
Record first received:  February 10, 2004
ClinicalTrials.gov Identifier:  NCT00077168
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08