Status:
COMPLETED
Acolbifene in Preventing Cancer in Premenopausal Women at High Risk of Breast Cancer
Lead Sponsor:
University of Kansas Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
30-55 years
Phase:
PHASE2
Brief Summary
This phase II trial is studying how well acolbifene works in preventing cancer in premenopausal women at high risk of breast cancer. Chemoprevention is the use of certain drugs to keep cancer from for...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the effect of six months of acolbifene 20 mg/day on Ki-67 in high risk premenopausal women with baseline hyperplasia +/- atypia and Ki-67 positivity of \>= 2%.. S...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Gail risk \>= 1.7% and/or relative risk \>= 3 times that for 5-year age group
- Premenopausal
- More than 6 months since initiating or discontinuing oral contraceptives
- At increased risk for breast cancer, as indicated by \>= 1 of the following risk factors:
- BRCA1/2 mutation characterized as deleterious or of uncertain significance
- Prior atypical ductal hyperplasia, ductal carcinoma in situ, or lobular carcinoma in situ
- Prior random periareolar fine needle aspiration (RPFNA) showing atypical hyperplasia
- Family history consistent with hereditary breast cancer, as indicated by 1 of the following criteria:
- \>= 4 relatives with breast cancer
- \>= 2 relatives diagnosed with breast cancer at ≤ 50 years of age
- Breast and ovarian cancer diagnosed in same relative
- No suspicion for breast cancer on baseline mammogram performed between days 1-10 of menstrual cycle within 3 months prior to screening baseline RPFNA
- Exhibits hyperplasia with or without atypia (Masood score \>= 14) with \>= 500 cells AND Ki-67 positivity \>= 2% by RPFNA performed within 6 months prior to initiation of study drug
- Estimated visual mammographic breast density category \>= 5% on mammogram performed within 6 months prior to initiation of study drug
- Has regular menstrual cycles (between 21 and 35 days) unless using extended regimen oral contraceptives or a contraceptive device (e.g., Mirena IUD) Values for metabolic profile and blood count within normal limits
- Absolute granulocyte count \> 1,000/mm\^3
- Platelets \> 100,000/mm\^3
- Hemoglobin \> 10 g/dL
- Bilirubin \< 2.0 mg/dL
- AST \< 2 times upper limit of normal (ULN)
- Albumin \> 3.0 g/dL
- Creatinine \< 1.5 mg/dL
- Alkaline phosphatase \< 2 times ULN
- Concurrent hormonal contraceptives allowed provided patient remains on the same hormonal regimen from 3 months prior to baseline aspiration until the completion of study treatment
- Fertile patients must use effective contraception during and for 3 months after completion of study treatment
- Willing to ingest recommended dose of calcium and vitamin D for premenopausal bone health (1,200 mg calcium and 800 IU vitamin D daily)
- Negative pregnancy test prior to receiving study agent
- Exclusion Criteria
- pregnant or nursing
- nursing within the past 6 months
- Known osteoporosis or severe osteopenia (T-score -2 or worse by DEXA)
- History of symptomatic endometriosis with pelvic pain, poorly controlled migraines, or hot flashes
- History of deep venous thrombosis
- History of allergic reactions attributed to compounds of similar chemical or biological composition to the study agent
- Other condition or concurrent illness that, in the opinion of the investigator, would make the patient a poor candidate for RPFNA
- Less than 1 year since prior use of aromatase inhibitors (e.g., anastrozole, exemestane, or letrozole) or selective estrogen receptor modulators (e.g., tamoxifen citrate, raloxifene, or arzoxifene hydrochloride)
- Other concurrent chemopreventive agents
- Concurrent anticoagulants
- Other concurrent investigational agents
- Bilateral breast implants
Exclusion
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00853996
Start Date
February 1 2009
End Date
December 1 2010
Last Update
January 17 2018
Active Locations (1)
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1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160