Status:
COMPLETED
Adjuvant Tamoxifen Compared With Anastrozole in Treating Postmenopausal Women With Ductal Carcinoma In Situ
Lead Sponsor:
Queen Mary University of London
Collaborating Sponsors:
Cancer Research UK
Conditions:
Breast Cancer
Eligibility:
FEMALE
40-70 years
Phase:
PHASE3
Brief Summary
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using either tamoxifen or anastrozole may fight breast cancer by blocking the use of estrogen. It is not yet known ...
Detailed Description
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 ducta...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2021
Estimated Enrollment :
2980 Patients enrolled
Trial Details
Trial ID
NCT00072462
Start Date
September 1 2003
End Date
May 31 2021
Last Update
September 19 2024
Active Locations (97)
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1
Australia
Newcastle, Australia
2
Austrian Breast & Colorectal Cancer Study Group
Vienna, Austria
3
Belgium
Leuven, Belgium
4
Chile
Santiago, Chile