At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed breast cancer, Stage IV with clinical and/or radiological evidence of metastatic disease
- ✓Measurable disease (≥1 lesion outside prior radiation field if radiotherapy given)
- ✓Female sex
- ✓SWOG performance status 0-2
- ✕Active CNS metastases
- ✕No more than 2 prior cytotoxic chemotherapy regimens for metastatic disease
- ✕Prior gemcitabine hydrochloride
- ✕Serious systemic disorder that would preclude study compliance
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Trial of Gemcitabine and Genistein in Metastatic Breast Cancer Patients With Biomarker Assays
In Brief
A Phase 2 clinical trial evaluating genistein, gemcitabine, and 1 other intervention for Breast Cancer. Completed, enrolled 19 participants across 1 site.
Detailed 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.
Study Details
Timeline
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)