Anastrozole in Preventing Breast Cancer in Postmenopausal Women at Increased Risk of Breast Cancer - NCT00078832-Concepcion - 0019 (Clinical Trial 119462)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy119462.aspx
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Concepcion |
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Country:
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Chile |
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| Conditions: |
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Breast Cancer |
| Purpose: |
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RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the
development of cancer. Anastrozole may be effective in preventing breast cancer.
PURPOSE: This randomized clinical trial is studying how well anastrozole works in preventing
breast cancer in postmenopausal women who are at increased risk for the disease.
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| Study summary: |
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OBJECTIVES:
Primary
- Determine the effectiveness of anastrozole in preventing breast cancer in
postmenopausal women at increased risk for the disease.
Secondary
- Determine the role of this drug in preventing estrogen receptor-positive breast cancer
in these participants.
- Determine the effect of this drug on breast cancer mortality in these participants.
- Determine the effect of this drug on other cancers, cardiovascular disease, fracture
rates, and non-breast cancer deaths in these participants.
- Determine the tolerability and acceptability of side effects of this drug in these
participants.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study.
Participants are stratified according to participating center. Participants are randomized
to 1 of 2 treatment arms.
- Arm I: Participants receive oral anastrozole daily for 5 years.
- Arm II: Participants receive an oral placebo daily for 5 years. In both arms, treatment
continues in the absence of the development of breast cancer (including ductal
carcinoma in situ), a drop in the T-score below minus 4, or the occurrence of a new
fragility fracture.
Participants are followed for 5 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 6,000 participants will be accrued for this study. |
| Criteria: |
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DISEASE CHARACTERISTICS:
- Meets at least 1 of the relative risk factors based on age as follows:
- 45 to 70 years of age:
- First-degree relative who developed breast cancer at ≤ 50 years of age
- First-degree relative who developed bilateral breast cancer
- Two or more first- or second-degree relatives who developed breast cancer
or ovarian cancer
- Participants having both relatives who are second degree and on the
opposite sides of the family must have at least one that was diagnosed
at ≤ 50 years of age
- Nulliparous (or first birth at ≥ 30 years of age) and a first-degree
relative who developed breast cancer
- Benign biopsy with proliferative disease and a first-degree relative who
developed breast cancer
- Mammographic opacity covering at least 50% of the breast in the absence of
hormone replacement therapy within the past 3 months
- 60 to 70 years of age:
- First-degree relative with breast cancer at any age
- Age at menopause ≥ 55 years
- Nulliparous or age at first birth ≥ 30 years
- 40 to 44 years of age:
- Two or more first- or second-degree relatives who developed breast cancer
or ovarian cancer at ≤ 50 years of age
- First-degree relative with bilateral breast cancer who developed the first
breast cancer at ≤ 50 years of age
- Nulliparous (or first birth at ≥ 30 years of age) and a first-degree
relative who developed breast cancer at ≤ 40 years of age
- Benign biopsy with proliferative disease and a first-degree relative who
developed breast cancer at ≤ 40 years of age
- All age groups (40 to 70 ears of age) with a 10-year risk > 5% who do not fit into
the above categories are allowed
- Clearly apparent family history AND/OR other risk factors indicating appropriate
increased risk of breast cancer for age
- The following prior breast conditions are allowed (for all age groups):
- Lobular carcinoma in situ
- Atypical ductal or lobular hyperplasia in a benign lesion
- Ductal carcinoma in-situ (DCIS), diagnosed within the past 6 months, and treated
by mastectomy
- No evidence of breast cancer on mammogram within the past year
- Hormone receptor status:
- For patients with prior DCIS, estrogen- or progesterone-receptor status must
have been positive
- Must have had > 5% positive cells
PATIENT CHARACTERISTICS:
Age
- 40 to 70
Sex
- Female
Menopausal status
- Postmenopausal, defined as at least 1 of the following:
- Over 60 years of age
- Bilateral oophorectomy
- ≤ 60 years of age with a uterus and amenorrhea for at least 12 months
- ≤ 60 years of age without a uterus and with follicle-stimulating hormone levels
> 30 IU/L
Performance status
- Not specified
Life expectancy
- At least 10 years
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Other
- Psychologically and physically suitable to receive 5 years of anti-estrogen therapy
- No cancer within the past 5 years except nonmelanoma skin cancer or carcinoma in situ
of the cervix
- No evidence of osteoporosis or fragility fractures within the spine
- Participants with a T-score > minus 4 and no more than 2 fragility fractures are
allowed
- No concurrent severe disease that would place the participant at unusual risk or
confound the results of the study
- No other medical condition that would preclude the ability to receive the study
treatment
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- No prior tamoxifen, raloxifene, or other selective estrogen receptor modulator (SERM)
use for more than 3 months in duration
- No concurrent tamoxifen, raloxifene, or other SERM
- No concurrent estrogen-based hormone replacement therapy
- No concurrent systemic estrogen replacement therapy, including vaginal estrogen
preparations
Radiotherapy
- Not specified
Surgery
- See Disease Characteristics
- No prior prophylactic mastectomy
- No concurrent prophylactic mastectomy
Other
- More than 3 months since prior investigational drugs
- No prior participation in IBIS-I
- No concurrent participation in IBIS-I |
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| Study is available at: |
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Clinica Sanatorio Aleman de Concepcion Edificio Centro
Concepcion
Chile
Primary Contact:
Contact Person
Phone: 56-41-279-6430 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 3, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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