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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00077168
• Other study ID #: CDR0000349580
• Secondary ID: ICR-DCIS-IIEU-20
• Status: Active, not recruiting
• Phase: Phase 2
• First received: February 10, 2004
• Last updated: February 6, 2009
• Start date: April 2004

Study information

• Verified date: October 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2000
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Carcinoma in Situ
• Carcinoma, Ductal
• Carcinoma, Intraductal, Noninfiltrating

Intervention

Drug:
• anastrozole

• tamoxifen citrate

Procedure:
• adjuvant therapy

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United Kingdom	Aberdeen Royal Infirmary at NHS Grampian	Aberdeen	Scotland
United Kingdom	Ysbyty Gwynedd	Bangor	Wales
United Kingdom	Bristol Haematology and Oncology Centre	Bristol	England
United Kingdom	Frenchay Hospital at North Bristol NHS Trust	Bristol	England
United Kingdom	Broomfield Hospital	Broomefield	England
United Kingdom	University Hospital of Wales	Cardiff	Wales
United Kingdom	Chelmsford and Essex Centre	Chelmsford	England
United Kingdom	Essex County Hospital	Colchester	England
United Kingdom	Derbyshire Royal Infirmary	Derby	England
United Kingdom	Queen's Hospital	Derby	England
United Kingdom	Dorset County Hospital	Dorchester	England
United Kingdom	Ninewells Hospital	Dundee	Scotland
United Kingdom	University of Glasgow	Glasgow	Scotland
United Kingdom	St. Luke's Cancer Centre at Royal Surrey County Hospital	Guildford	England
United Kingdom	Leeds Cancer Centre at St. James's University Hospital	Leeds	England
United Kingdom	Lincoln County Hospital	Lincoln	England
United Kingdom	Charing Cross Hospital	London	England
United Kingdom	South Manchester University Hospital	Manchester	England
United Kingdom	Clatterbridge Centre for Oncology NHS Trust	Merseyside	England
United Kingdom	Milton Keynes General Hospital	Milton Keynes	England
United Kingdom	Derriford Hospital	Plymouth	England
United Kingdom	Poole Hospital NHS Trust	Poole Dorset	England
United Kingdom	Berkshire Cancer Centre at Royal Berkshire Hospital	Reading	England
United Kingdom	Scarborough General Hospital	Scarborough	England
United Kingdom	University Hospital of North Tees	Stockton-On-Tees	England
United Kingdom	Royal Marsden NHS Foundation Trust - Surrey	Sutton	England
United Kingdom	Torbay Hospital	Torquay Devon	England
United Kingdom	Hillingdon Hospital	Uxbridge	England
United Kingdom	Worcester Royal Hospital	Worcester	England

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Cancer Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Local tumor control (invasive and in situ local recurrence)			No
Secondary	Mastectomy rate			No
Secondary	Pattern of relapse in the breast			No
Secondary	Contralateral primary			No
Secondary	Breast cancer metastases			No
Secondary	Mortality			No
Secondary	Quality of life			No
Secondary	Molecular markers that predict ipsilateral tumor recurrence			No