At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed metastatic breast cancer with measurable disease (≥1 lesion ≥10 mm on CT/MRI or physical exam)
- ✓Prior aromatase inhibitor in adjuvant or metastatic setting with documented disease recurrence or progression on that therapy
- ✓Estrogen receptor-positive and/or progesterone receptor-positive (>1% staining by IHC or >10 fmol/mg by binding assay)
- ✓Postmenopausal status (bilateral oophorectomy, ≥12 months amenorrhea, FSH in postmenopausal range, age ≥60, or on goserelin)
- ✕Estrogen receptor status unknown
- ✕Progesterone receptor status unknown
- ✕Premenopausal status
- ✕Performance status 3 or 4
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I/II Trial of BAY 43-9006 (Sorafenib) in Combination With Anastrozole in Patients With Metastatic Breast Cancer
In Brief
A Phase 2 clinical trial evaluating sorafenib tosylate and anastrozole for Recurrent Breast Cancer and Stage IV Breast Cancer. Completed, enrolled 35 participants across 1 site.
Detailed Summary
Sorafenib may stop the growth of tumor cells by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth. Estradiol can cause the growth of breast cancer. Hormone therapy using anastrozole may fight breast cancer by blocking the use of estradiol by the tumor cells. Sometimes when hormone therapy is given, it does not stop the growth of tumor cells. The tumor is said to be resistant to hormone therapy. Giving sorafenib together with anastrozole may reduce drug resistance and allow the tumor cells to be killed. This phase I/II trial is studying the side effects and best dose of sorafenib when given in combination with anastrozole and to see how well they work in treating postmenopausal women with metastatic breast cancer.
Study Details
Timeline
Interventions
Given orally
Given orally