At a glance
ClinicalIndex Comparison Record- ✓Estrogen and/or progesterone receptor positive histologically confirmed adenocarcinoma of the breast with measurable recurrent or metastatic carcinoma
- ✓Postmenopausal females defined by prior bilateral oophorectomy/ovarian irradiation, or ≥12 months without menstrual period (or if ≤55 years and on tamoxifen within 6 months, postmenopausal estradiol level required)
- ✓≤2 prior chemotherapy regimens for metastatic disease; no chemotherapy within 3 weeks prior to randomization
- ✓ECOG performance status 0, 1, or 2
- ✕Prior hormonal therapy for metastatic disease; no prior aromatase inhibitors or fulvestrant in adjuvant setting
- ✕Prior therapy with agents that target EGFR
- ✕History of CNS metastases
- ✕Currently receiving anticoagulants or have contraindication to intramuscular injections
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Phase II Trial of Combination Anastrozole (NSC #719344) Plus ZD1839 (Iressa, NSC #715055, IND #61187) and of Combination Fulvestrant (NSC #719276) Plus ZD1839 in the Treatment of Postmenopausal Women With Hormone Receptor-Positive Metastatic Breast Cancer
In Brief
A Phase 2 clinical trial evaluating anastrozole, gefitinib, and 2 other interventions for Estrogen Receptor-positive Breast Cancer and 3 related conditions. Completed, enrolled 148 participants across 1 site.
Detailed Summary
This randomized phase II trial is studying how well giving gefitinib together with anastrozole works compared to giving gefitinib together with fulvestrant in treating postmenopausal women with recurrent or metastatic breast cancer. Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using anastrozole and fulvestrant may fight breast cancer by blocking the use of estrogen. Gefitinib (ZD1839) may stop the growth of cancer cells by blocking the enzymes necessary for their growth. It is not yet known whether gefitinib is more effective when combined with anastrozole or fulvestrant in treating breast cancer.
Study Details
Timeline
Interventions
Given orally
Given orally
Given intramuscularly
Correlative studies