Docetaxel Plus Garlic in Treating Patients With Locally Advanced or Metastatic Breast Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed adenocarcinoma of the breast
• Incurable, locally advanced or metastatic disease for which therapy with docetaxel is a reasonable option
• No documentation of progressive disease while on docetaxel within the past 2 months
• Brain and/or leptomeningeal metastases are allowed only if all of the following criteria are met:
• * Asymptomatic on neurological examination, including after definitive radiotherapy
• * No corticosteroid therapy to control symptoms
• * Stable lesions
• Hormone receptor status:
• * Not specified
• PATIENT CHARACTERISTICS:
• Age
• 18 and over
• Sex
• Male or female
• Menopausal Status
• Not specified
• Performance status
• ECOG 0-2
• Life expectancy
• At least 12 weeks
• Hematopoietic
• Neutrophil count ≥ 1,200/mm\^3
• Platelet count ≥ 100,000/mm\^3
• Hepatic
• Bilirubin normal
• ALT and AST ≤ 2 times ULN (3 times ULN with liver metastases)
• Renal
• Creatinine normal OR
• Creatinine clearance ≥ 60 mL/min
• Cardiovascular
• No symptomatic congestive heart failure
• No unstable angina pectoris
• No cardiac arrhythmias
• Gastrointestinal
• No known gastric emptying disorders
• No persistent diarrhea
• Other
• No uncontrolled diabetes mellitus
• No active infection
• No prior grade 3 or 4 allergic reaction attributed to compounds of similar biological composition to garlic, docetaxel, or Tween 80
• No other concurrent uncontrolled medical condition that would preclude study participation
• No psychiatric illness or social situation that would preclude study compliance
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective barrier contraception
• Must be able to ingest oral medication
• Lactic dehydrogenase ≤ 2 times ULN
• PRIOR CONCURRENT THERAPY:
• Biologic therapy
• At least 3 weeks since prior immunotherapy
• No concurrent immunotherapy
• * Trastuzumab (Herceptin®) allowed after the first course of therapy at the discretion of the primary physician
• No concurrent pegfilgrastim
• Chemotherapy
• See Disease Characteristics
• At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
• No other concurrent chemotherapy
• Endocrine therapy
• See Disease Characteristics
• At least 2 weeks since prior hormonal therapy
• No concurrent hormonal therapy
• No concurrent megestrol during the first course of study treatment
• Radiotherapy
• See Disease Characteristics
• At least 3 weeks since prior radiotherapy
• No concurrent radiotherapy
• Surgery
• Not specified
• Other
• More than 30 days (or 5 half-lives) since prior investigational therapy
• No concurrent aprepitant (Emend®)
• No concurrent or oral tetrahydrocannabinol (Marinol®) during the first course of study treatment
• No concurrent combination antiretroviral therapy for HIV-positive patients
• No other concurrent investigational or anticancer medications
• No concurrent antiepileptic therapy
• No concurrent immunosuppressants
• No other concurrent herbal therapies during the first month of study participation
• No concurrent grapefruit juice during the first month of study participation
• No concurrent administration of the following:
• * Alprazolam
• * Cyclosporine
• * Diltiazem
• * Dofetilide
• * Erythromycin
• * Fluvoxamine
• * Itraconazole
• * Ketoconazole
• * Quinine
• * Hypericum perforatum (St. John's wort)
• * Tacrolimus
• * Theophylline
• * Warfarin
• * Zolpidem