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
- Conditions
- Breast Cancer
- Registration Number
- NCT00077168
- Lead Sponsor
- Institute of Cancer Research, United Kingdom
- Brief 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.
- Detailed 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 & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 2000
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Local tumor control (invasive and in situ local recurrence)
- Secondary Outcome Measures
Name Time Method Mastectomy rate Pattern of relapse in the breast Contralateral primary Breast cancer metastases Mortality Quality of life Molecular markers that predict ipsilateral tumor recurrence
Trial Locations
- Locations (29)
Berkshire Cancer Centre at Royal Berkshire Hospital
🇬🇧Reading, England, United Kingdom
Derriford Hospital
🇬🇧Plymouth, England, United Kingdom
Poole Hospital NHS Trust
🇬🇧Poole Dorset, England, United Kingdom
Milton Keynes General Hospital
🇬🇧Milton Keynes, England, United Kingdom
Lincoln County Hospital
🇬🇧Lincoln, England, United Kingdom
Scarborough General Hospital
🇬🇧Scarborough, England, United Kingdom
Broomfield Hospital
🇬🇧Broomefield, England, United Kingdom
Derbyshire Royal Infirmary
🇬🇧Derby, 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
Aberdeen Royal Infirmary at NHS Grampian
🇬🇧Aberdeen, Scotland, United Kingdom
Worcester Royal Hospital
🇬🇧Worcester, England, United Kingdom
Chelmsford and Essex Centre
🇬🇧Chelmsford, England, United Kingdom
Queen's Hospital
🇬🇧Derby, England, United Kingdom
Hillingdon Hospital
🇬🇧Uxbridge, England, United Kingdom
Frenchay Hospital at North Bristol NHS Trust
🇬🇧Bristol, England, United Kingdom
Clatterbridge Centre for Oncology NHS Trust
🇬🇧Merseyside, England, United Kingdom
University Hospital of North Tees
🇬🇧Stockton-On-Tees, England, United Kingdom
Bristol Haematology and Oncology Centre
🇬🇧Bristol, England, United Kingdom
Ninewells Hospital
🇬🇧Dundee, Scotland, United Kingdom
University of Glasgow
🇬🇧Glasgow, Scotland, United Kingdom
South Manchester University Hospital
🇬🇧Manchester, England, United Kingdom
Essex County Hospital
🇬🇧Colchester, England, United Kingdom
Dorset County Hospital
🇬🇧Dorchester, England, United Kingdom
Royal Marsden NHS Foundation Trust - Surrey
🇬🇧Sutton, England, United Kingdom
Torbay Hospital
🇬🇧Torquay Devon, England, United Kingdom
Ysbyty Gwynedd
🇬🇧Bangor, Wales, United Kingdom
University Hospital of Wales
🇬🇧Cardiff, Wales, United Kingdom
Charing Cross Hospital
🇬🇧London, England, United Kingdom