Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 40 to 70 Other ICR-DCIS-II EU-20341, NCT00077168

Objectives

Primary

1. 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.
2. Compare the quality of life of patients treated with these regimens.

Secondary

1. Determine the minimal surgical margins required to minimize the local recurrence rate in patients treated with these regimens.
2. Identify molecular markers that predict ipsilateral tumor recurrence in patients treated with these regimens.

Entry 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 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

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

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

Expected Enrollment

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

Outcomes

Local tumor control (invasive and in situ local recurrence)

Mastectomy rate
Pattern of relapse in the breast
Contralateral primary
Breast cancer metastases
Mortality
Quality of life
Molecular markers that predict ipsilateral tumor recurrence

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

Trial Contact Information

Trial Lead Organizations

Institute of Cancer Research - Sutton

Ronald Kaggwa, Study coordinator		Ph: 44-208-722-4

Registry Information
Official Title		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
Trial Start Date		2004-04-01
Trial Completion Date		2017-09-30 (estimated)
Registered in ClinicalTrials.gov		NCT00077168
Date Submitted to PDQ		2003-12-11
Information Last Verified		2007-10-14

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