IBIS-II DCISInternational Breast Cancer Intervention Study II (IBIS-II) (DCIS)
tamoxifen citrate
+ Anastrozole
Breast Diseases+6
+ Breast Neoplasms
+ Carcinoma
Treatment Study
Summary
Study start date: September 1, 2003
Actual date on which the first participant was enrolled.OBJECTIVES: Primary * Compare the efficacy of adjuvant tamoxifen vs anastrozole, in terms of local control and prevention of contralateral disease, in postmenopausal women with locally excised ductal carcinoma in situ. * Compare side effect profiles of these drugs in these patients. Secondary * Compare the efficacy of these drugs, according to the receptor status of the primary or recurrent cancer in these patients. * Compare the rate of breast cancer recurrence and growth of new contralateral tumors after cessation of treatment with these drugs in these patients. * Compare breast cancer mortality in patients treated with these drugs. * Compare the effect of these drugs on other cancers, cardiovascular disease, fracture rates, and non-breast cancer deaths in these patients. * Compare the tolerability and acceptability of side effects experienced by patients treated with these drugs. OUTLINE: This is a randomized, double-blind, multicentre study. Patients are stratified according to participating centre. Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive oral tamoxifen and oral placebo once daily. * Arm II: Patients receive oral anastrozole and oral placebo once daily. In both arms, treatment continues for 5 years in the absence of disease recurrence or unacceptable toxicity. Patients are followed annually for 5 years and a further 5 years (minimum) off treatment. Peer Reviewed and Funded by Cancer Research UK. Sponsored by Queen Mary University of London ACTUAL ACCRUAL: A total of 2,980 patients were accrued for this study over 9 years.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.2980 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 ductal carcinoma in situ within the past 6 months * Locally excised with tumor-free margins at least 1 mm * Hormone receptor status: * Estrogen or progesterone receptor positive * Equal to or greater than 5% positive cells PATIENT CHARACTERISTICS: Age * 40 to 70 Sex * Female Menopausal status * Postmenopausal, defined as meeting at least 1 of the following criteria: * Over age 60 * Prior bilateral oophorectomy * Age 60 or under with a uterus AND amenorrhea for at least the past 12 months * Age 60 or under without a uterus AND follicle-stimulating hormone greater than 20 IU/L Performance status * Not specified Life expectancy * At least 10 years Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Cardiovascular * No prior deep vein thrombosis * No prior transient ischemic attack * No prior cerebrovascular accident Pulmonary * No prior pulmonary embolism Other * No unexplained postmenopausal bleeding * No other cancer within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix * No other concurrent medical condition that would preclude study therapy, place the patient at unusual risk, or confound study results * No evidence of osteoporosis * Fragility fractures within the spine allowed if T-score level is greater than -4 and consist of no more than 2 fractures * Psychologically and physically suitable for 5 years of study therapy PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * No prior or concurrent tamoxifen use lasting more than 6 months unless treatment was completed more than 5 years ago. Women in IBIS-I can join if off trial therapy for at least 5 years. * No prior or concurrent raloxifene use lasting more than 6 months unless treatment was completed more than 5 years ago. * No other prior or concurrent selective estrogen-receptor modulator use lasting more than 6 months unless treatment was completed more than 5 years ago * No concurrent systemic estrogen-based hormone replacement therapy, including vaginal estrogen preparations Radiotherapy * Not specified Surgery * See Disease Characteristics * No prior mastectomy * No planned prophylactic mastectomy Other * At least 3 months since prior unapproved or experimental agents * No concurrent anticoagulants
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorGroup II
Active ComparatorStudy 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 97 locations
Austrian Breast & Colorectal Cancer Study Group
Vienna, AustriaBelgium
Leuven, BelgiumChile
Santiago, Chile