Clinical trial · Interventional
Gemcitabine Hydrochloride and Genistein in Treating Women With Stage IV Breast Cancer
Phase II Trial of Gemcitabine and Genistein in Metastatic Breast Cancer Patients With Biomarker Assays
NCT00244933CI-TRIAL-00067464completedPhase 2Results postedClinicalTrials.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 gemcitabine hydrochloride and genistein, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving gemcitabine hydrochloride together with genistein may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gemcitabine hydrochloride together with genistein works in treating women with stage IV 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gemcitabine | Drug | Gemcitabine | ALIAS |
| genistein | Dietary Supplement | — | UNRESOLVED |
| Tumor biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gemcitabine, genistein (Novasoy), Tumor biopsy
- description
- Gemcitabine IV-1000mg/m2: Days 1 \& 8 every 21 days Novasoy Orally-100 mg 2 times/day for 7 days; 2 times/day on Days 1-21 every 21 days.
- interventionNames
- Dietary Supplement: genistein
- Drug: gemcitabine
- Procedure: Tumor biopsy
Primary outcomes (1)
- measure
- Objective Response Rate by RECIST Criteria Following
- timeFrame
- every 2 courses until disease progression or death, up to 24 weeks
- description
- Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed breast cancer * Stage IV disease * Clinical and/or radiological evidence of metastatic disease * Measurable disease * Prior radiotherapy allowed provided there is ≥ 1 measurable disease site outside the radiation field * No active CNS metastases * Previously treated CNS metastases allowed provided disease is stable for ≥ 3 months without steroids or antiseizure medications * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Sex * Female Menopausal status * Not specified Performance status * SWOG 0-2 Life expectancy * Not specified Hematopoietic * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 10 g/dL Hepatic * Bilirubin ≤3.0 mg/dL * AST and ALT ≤ 2.5 times upper limit of normal Renal * Creatinine ≤ 1.5 mg/dL Other * Not pregnant or nursing * Fertile patients must use effective contraception * No serious systemic disorder that would preclude study compliance * No history of another malignancy except curatively treated carcinoma of the cervix or basal cell or squamous cell skin cancer in complete remission * No unresolved bacterial infection requiring antibiotic treatment * No known HIV-1 positivity PRIOR CONCURRENT THERAPY: Biologic therapy * At least 3 weeks since prior biologic therapy Chemotherapy * Prior adjuvant chemotherapy allowed * Prior adjuvant or neoadjuvant taxane-based therapy or taxane therapy for metastatic disease allowed * Patient must have failed therapy within 2 years after completion of treatment * At least 3 weeks since prior chemotherapy * No more than 2 prior cytotoxic chemotherapy regimens for metastatic disease * No prior gemcitabine hydrochloride * No other concurrent chemotherapy Endocrine therapy * See Disease Characteristics * At least 2 weeks since prior and no concurrent hormonal therapy * Must have documented disease progression during prior hormonal therapy Radiotherapy * See Disease Characteristics * At least 4 weeks since prior radiotherapy and recovered * No concurrent radiotherapy Surgery * At least 3 weeks since prior surgery Other * At least 3 weeks since prior investigational therapy * At least 1 week since prior soy supplements (e.g., soy-based pills, liquids, or concentrates) * Dietary soy as part of a meal (e.g., tofu) allowed once a week * No concurrent nutritional supplements, herbal agents, or high doses of antioxidants (e.g., vitamins C, D, or E) that may interact with, antagonize, alter, or imitate the potential effects of gemcitabine hydrochloride or genistein * A single daily multivitamin is allowed * No other concurrent immunotherapy * No other concurrent experimental medication * Concurrent anticoagulants, appetite stimulants, and replacement steroids allowed
References
Publications (0)
Data not yet available
No reference posted for this study.