Clinical trial · Interventional
Docetaxel Plus Garlic in Treating Patients With Locally Advanced or Metastatic Breast Cancer
A Pilot Study to Evaluate the Influence of Garlic on the Pharmacokinetics of Docetaxel in Patients With Metastatic Breast Cancer
NCT00079170CI-TRIAL-00010889completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether garlic supplements affect the ability of docetaxel to kill tumor cells. PURPOSE: This clinical trial is studying how well giving docetaxel together with garlic works in treating patients with locally advanced or metastatic breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| docetaxel | Drug | Docetaxel | ALIAS |
| garlic | Dietary Supplement | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.