At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed metastatic breast cancer (M1) or multiple sites of clinically obvious metastatic disease
- ✓Estrogen receptor positive and/or progesterone receptor positive (>10 fmol/mg cytosol protein by ligand binding assay or positive by immunohistochemistry)
- ✓Postmenopausal status (prior bilateral oophorectomy, >12 months since last menses, ≥55 years with hysterectomy, or <55 years with hysterectomy and menopausal hormone levels)
- ✓Female sex
- ✕Known brain or CNS metastases
- ✕Prior chemotherapy for recurrent or metastatic disease
- ✕Prior immunotherapy for recurrent or metastatic disease
- ✕Prior hormonal therapy for recurrent or metastatic disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase III Randomized Trial of Anastrozole Versus Anastrozole and Fulvestrant as First Line Therapy for Post Menopausal Women With Metastatic Breast Cancer
In Brief
A Phase 3 clinical trial evaluating anastrozole and fulvestrant for Breast Cancer. Completed, enrolled 695 participants across 426 sites in 2 countries.
Detailed Summary
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using drugs such as anastrozole and fulvestrant may fight breast cancer by blocking the use of estrogen. It is not yet known whether anastrozole is more effective with or without fulvestrant in treating breast cancer. PURPOSE: This randomized phase III trial is studying giving anastrozole together with fulvestrant to see how well it works compared to anastrozole alone as first-line therapy in treating postmenopausal women with metastatic breast cancer.
Study Details
Timeline
Interventions
Given orally
Given intramuscularly