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.

Condition	Treatment or Intervention	Phase
Breast Cancer	Drug: IH636 grape seed proanthocyanidin extract  Procedure: alternative product therapy  Procedure: aromatase inhibition  Procedure: biologically based therapies  Procedure: cancer prevention intervention  Procedure: chemoprevention of cancer  Procedure: complementary and alternative therapy  Procedure: dietary intervention  Procedure: endocrine therapy  Procedure: hormone therapy  Procedure: nutritional supplementation	Phase I

Further Study Details: 

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 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 suggested dose of this dietary supplement for 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 escalating doses 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.

Ages Eligible for Study:  50 Years   -   65 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

DISEASE CHARACTERISTICS:

• At increased risk of developing breast cancer, as defined by 1 of the following risk factors:
• Gail model 5-year risk ≥ 1.67%
• Gail or Claus model lifetime risk ≥ 15%
• No prior history of breast cancer or ductal carcinoma in situ

PATIENT CHARACTERISTICS: Age

• 50 to 65

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 cancer 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

California
      City of Hope Comprehensive Cancer Center, Duarte,  California,  91010-3000,  United States; Recruiting

Study ID Numbers:  CDR0000407637; CHNMC-IRB-03178; NCT00100893
Record last reviewed:  February 2005
Last Updated:  March 3, 2005
Record first received:  January 6, 2005
ClinicalTrials.gov Identifier:  NCT00100893
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08