Breast Cancer
Conditions
Keywords
metastatic breast cancer
Brief summary
This study is being carried out to see if treatment with ZD1839 (Gefitinib) combined with Arimidex (Anastrozole) has improved efficacy over Arimidex alone in preventing progression of metastatic breast cancer.
Detailed description
This is a phase II, multicenter, double-blind, randomized, placebo-controlled trial. Patients will be randomized in a double-blind manner in a 1:1 ratio to receive either 250 mg/day ZD1839 or matched placebo in combination with 1 mg/day anastrozole. The dose of ZD1839 has been selected based on clinical studies in other tumor types suggesting identical efficacy together with a better toxicity profile in patients treated at 250 mg compared to 500 mg/day. The 1 mg dose of anastrozole is the standard approved dose.
Interventions
DRUGGefitinib
ZD1839 (gefitinib, IRESSA) 250 mg/DAY PO + 1 mg Anastrozole (ZD1033, Arimidex)
DRUGAnastrozole
1 mg Anastrozole (ZD1033, Arimidex) + PLACEBO 1 TABLET/DAY PO
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female postmenopausal patients aged 18 years or older with newly diagnosed metastatic breast cancer. * Patients with recurrent disease during or after adjuvant tamoxifen or patients who are hormone therapy naïve are eligible for this trial. * A paraffin embedded tumor tissue block or slides from either the metastatic or primary tumor site is required.
Exclusion criteria
* Patients cannot be on hormone replacement therapy while on study. * Prior chemotherapy received for metastatic disease is not allowed. * Previous treatment with tyrosine kinase inhibitors or aromatase inhibitors is not allowed. * Patients who have evidence of an active interstitial lung disease are not eligible.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to progression | Duration of study | To estimate TTP in the 2 treatment arms of postmenopausal patients with newly diagnosed metastatic breast cancer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall clinical benefit rate | Duration of Study | To estimate the clinical benefit rates (CBR; defined as CR+PR\[as per RECIST\]+stable disease \[SD\]\>24 weeks) for the 2 treatment arms |
| Overall survival | Duration of Study | To estimate overall survival (OS) for each of the 2 treatment arms |
| Objective response rate | Duration of Study | To estimate the ORR (complete response \[CR\] and partial response \[PR\] as defined by RECIST for the 2 treatment arms |
| Pharmacokinetic variables | Duration of Study | To determine steady-state plasma trough concentrations of anastrozole in all patients. To determine steady-state trough concentrations of ZD1839 and to relate values to historical data |
| Biomarker objectives | Duration of Study | To obtain tumor tissue and blood samples for biologic studies in the limited population available and measure expression of markers that may potentially correlate with response to treatment in this patient population |
| Safety | Duration of Study | To compare the tolerability of anastrozole/placebo to that of anastrozole/ZD1839 |
Countries
Colombia, Mexico, United States, Venezuela
Outcome results
None listed