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
NCT ID: NCT00077168
Last Updated: 2009-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
2000 participants
INTERVENTIONAL
2004-04-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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anastrozole
tamoxifen citrate
adjuvant therapy
radiation therapy
Eligibility Criteria
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Inclusion Criteria
* 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
40 Years
70 Years
FEMALE
No
Sponsors
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Institute of Cancer Research, United Kingdom
OTHER
Principal Investigators
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Ronald Kaggwa
Role:
Institute of Cancer Research, United Kingdom
Locations
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Frenchay Hospital at North Bristol NHS Trust
Bristol, England, United Kingdom
Bristol Haematology and Oncology Centre
Bristol, England, United Kingdom
Broomfield Hospital
Broomefield, England, 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
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, United Kingdom
Aberdeen Royal Infirmary at NHS Grampian
Aberdeen, Scotland, United Kingdom
Ninewells Hospital
Dundee, Scotland, United Kingdom
University of Glasgow
Glasgow, Scotland, United Kingdom
Ysbyty Gwynedd
Bangor, Wales, United Kingdom
University Hospital of Wales
Cardiff, Wales, United Kingdom
Countries
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Other Identifiers
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ICR-DCIS-II
Identifier Type: -
Identifier Source: secondary_id
EU-20341
Identifier Type: -
Identifier Source: secondary_id
CDR0000349580
Identifier Type: -
Identifier Source: org_study_id
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