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
Data Collection
Breast Carcinoma In Situ+7
+ Adenocarcinoma
+ Carcinoma
Treatment Study
Summary
Study start date: April 1, 2004
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.2000 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 40 to 70 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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 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 Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 29 locations
Bristol Haematology and Oncology Centre
Bristol, United KingdomBroomfield Hospital
Broomefield, United KingdomChelmsford and Essex Centre
Chelmsford, United Kingdom