At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed adenocarcinoma of the breast with locally advanced or metastatic disease
- ✓Relapsed or progressed during prior single-agent nonsteroidal aromatase inhibitor (NSAI) therapy, with either NSAI given as adjuvant therapy ≥12 months OR objective response/stable disease ≥6 months with first-line NSAI for advanced/metastatic disease
- ✓Metastatic disease must be measurable or evaluable; bone-only metastases eligible if evaluable site can be followed by imaging
- ✓Estrogen receptor and/or progesterone receptor positive tumor; ER-unknown disease excluded
- ✕Rapidly progressive visceral disease (lymphangitis carcinomatosa or diffuse hepatic involvement)
- ✕ER-unknown disease
- ✕Other malignancy within past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of cervix
- ✕Systemic corticosteroids lasting >15 days within past 4 weeks
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Partially Blind Phase III Randomised Trial of Faslodex +/- Concomitant Arimidex Compared With Exemestane in Post-menopausal Women With ER+ or PR+ Locally Advanced/Metastatic Breast Cancer Following Progression on Non-steroidal AIs
In Brief
A Phase 3 clinical trial evaluating Anastrozole, Exemestane, and 1 other intervention for Breast Cancer. Completed, enrolled 698 participants across 2 sites.
Detailed Summary
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using fulvestrant, anastrozole, or exemestane may fight breast cancer by blocking the use of estrogen by the tumor cells or by lowering the amount of estrogen the body makes. It is not yet known whether giving fulvestrant together with anastrozole is more effective than giving fulvestrant together with a placebo or exemestane alone in treating breast cancer. PURPOSE: This randomized phase III trial is studying fulvestrant and anastrozole to see how well they work compared to fulvestrant and a placebo or exemestane alone in treating postmenopausal women with locally advanced or metastatic breast cancer.
Study Details
Timeline
Interventions
This may be Anastrazole OR a placebo