Breast Cancer
Conditions
Keywords
stage IV breast cancer, recurrent breast cancer
Brief summary
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
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.
Interventions
Novasoy Orally-100 mg 2 times/day for 7 days; 2 times/day on Days 1-21 every 21 days.
Gemcitabine IV-1000mg/m2: Days 1 & 8 every 21 days
Biopsy of tumor prior to dose of genistein (Novasoy)
Sponsors
Study design
Eligibility
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate by RECIST Criteria Following | every 2 courses until disease progression or death, up to 24 weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Gemcitabine, Genistein (Novasoy), Tumor Biopsy 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.
genistein: Novasoy Orally-100 mg 2 times/day for 7 days; 2 times/day on Days 1-21 every 21 days.
gemcitabine: Gemcitabine IV-1000mg/m2: Days 1 & 8 every 21 days
Tumor biopsy: Biopsy of tumor prior to dose of genistein (Novasoy) | 19 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Not response evaluable | 2 |
Baseline characteristics
| Characteristic | Gemcitabine, Genistein (Novasoy), Tumor Biopsy |
|---|---|
| Age, Continuous | 53 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Region of Enrollment United States | 19 participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 19 |
| serious Total, serious adverse events | 5 / 19 |
Outcome results
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.
Time frame: every 2 courses until disease progression or death, up to 24 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gemcitabine & Genistein | Objective Response Rate by RECIST Criteria Following | 0 participants |