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

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