Breast Cancer Clinical Trial
IH636 Grape Seed Extract in Preventing Breast Cancer in Postmenopausal Women at Risk of Developing Breast Cancer
Summary
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of IH636 grape seed extract may prevent breast cancer.
PURPOSE: This phase I trial is studying the side effects and best dose of IH636 grape seed extract in preventing breast cancer in postmenopausal women at risk of developing breast cancer.
Full Description
OBJECTIVES:
Determine the efficacy of IH636 grape seed proanthocyanidin extract, in terms of suppression of estrogen biosynthesis, in healthy post-menopausal women at high risk of developing breast cancer.
Determine the safety and tolerability of this dietary supplement, in terms of symptoms and changes in markers of bone and lipid metabolism and in markers of nonspecific adrenal suppression, in these participants.
Determine, preliminarily, an optimum biologic dose of this dietary supplement, as defined by suppression of serum estradiol, in these participants.
Determine a minimum duration of use of this dietary supplement to achieve aromatase inhibition in these participants.
OUTLINE: This is a pilot, dose-finding, placebo-controlled study.
Participants receive oral placebo once or twice daily on days -14 to 0. Participants then receive oral IH636 grape seed proanthocyanidin extract once or twice daily on days 1-85. Treatment continues in the absence of toxicity.
Cohorts of 6 participants receive one of four dose levels of IH636 grape seed proanthocyanidin extract up to an established safe dose.
PROJECTED ACCRUAL: A total of 24 participants will be accrued for this study within 12 months.
Eligibility Criteria
DISEASE CHARACTERISTICS:
At risk of developing breast cancer
No history of breast cancer or ductal carcinoma in situ
PATIENT CHARACTERISTICS:
Age
40 to 75
Sex
Female
Menopausal status
Postmenopausal, defined by 1 of the following criteria:
No spontaneous menses for ≥ 12 months
Prior bilateral oophorectomy
Prior hysterectomy with follicle-stimulating hormone within menopausal range
Performance status
ECOG 0-1
Life expectancy
Not specified
Hematopoietic
Hemoglobin ≥ 9.0 g/dL
Platelet count ≥ 100,000/mm^3
WBC ≥ 3,500/mm^3
Absolute granulocyte count ≥ 1,500/mm^3
No coagulation disorders
Hepatic
SGOT and SGPT ≤ 2 times upper limit of normal (ULN)
Bilirubin ≤ 1.5 times ULN
Renal
Creatinine ≤ 1.5 times ULN
Cardiovascular
No major illness of the cardiovascular system
Pulmonary
No major illness of the respiratory system
Other
No history of other invasive cancer within the past 5 years except squamous cell or basal cell skin cancer
No major systemic infection
No Cushing's syndrome or adrenal insufficiency
No osteoporosis, defined as a bone mineral density T-score ≥ -2.5 on dual-energy x-ray absorptiometry scan (calcium and/or cholecalciferol [vitamin D] supplementation AND/OR bisphosphonate therapy allowed provided participant is on a stable dose during study participation)
PRIOR CONCURRENT THERAPY:
Biologic therapy
Not specified
Chemotherapy
Not specified
Endocrine therapy
More than 3 months since prior hormone-modifying medications, including any of the following:
Oral contraceptives
Hormone replacement therapy
Selective estrogen receptor modifiers
Aromatase inhibitors
Gonadotropin-releasing hormone modifiers
Concurrent dehydroepiandrosterone (DHEA) allowed, provided dose remains constant during study participation
Radiotherapy
Not specified
Surgery
Not specified
Other
No red wine, red grapes, or white button mushrooms directly before or during study treatment
White and seedless grapes allowed
No other concurrent therapy
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There is 1 Location for this study
Duarte California, 91010, United States
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