Gemcitabine Hydrochloride and Genistein in Treating Women With Stage IV Breast Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: Primary Determine the objective response rate in patients with stage IV breast cancer treated with gemcitabine hydrochloride and genistein. Secondary Determine the duration of response and survival of patients treated with this regimen. Determine the time to disease progression in patients treated with this regimen. Determine the quantitative and qualitative toxic effects of this regimen in these patients. Correlate plasma genistein levels with response in patients treated with this regimen. OUTLINE: Patients receive oral genistein once daily on days -7 to 1. Patients also receive gemcitabine hydrochloride IV on days 1 and 8 and oral genistein once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.

Official Title
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Phase II Trial of Gemcitabine and Genistein in Metastatic Breast Cancer Patients With Biomarker Assays

Conditions
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Breast Cancer

Intervention / Treatment
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* Dietary Supplement: genistein
* Drug: gemcitabine
* Procedure: Tumor biopsy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gemcitabine, genistein (Novasoy), Tumor biopsy<br>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. | Dietary Supplement: genistein<br>* Novasoy Orally-100 mg 2 times/day for 7 days; 2 times/day on Days 1-21 every 21 days.<br>* Other names: Novasoy;Drug: gemcitabine<br>* Gemcitabine IV-1000mg/m2: Days 1 & 8 every 21 days<br>* Other names: Gemzar®;Procedure: Tumor biopsy<br>* Biopsy of tumor prior to dose of genistein (Novasoy)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate by RECIST Criteria Following | 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. | every 2 courses until disease progression or death, up to 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent breast cancer, stage IV breast cancer