Comparing Anastrozole-Placebo to the Combination Anastrozole-ZD1839 in Postmenopausal Patients With Estrogen Receptor and/or Progesterone Receptor Metastatic Breast Cancer

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Anastrozole; Drug: Gefitinib

• Registration Number: NCT00077025
• Lead Sponsor: AstraZeneca

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.

Study Timeline

• Study Start: 2004-01
• Study First Submitted: 2004-02-09
• Study First Submitted QC: 2004-02-10
• Study First Posted: 2004-02-11
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-15
• Last Update Posted: 2014-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 174

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anastrozole-placebo	Anastrozole	Anastrozole (ZD1033, Arimidex)-Placebo
Anastrozole-ZD1839	Gefitinib	Anastrozole (ZD1033, Arimidex)-ZD1839 (gefitinib, IRESSA)

Primary Outcome Measures

Name	Time	Method
Time to progression	Duration of study	To estimate TTP in the 2 treatment arms of postmenopausal patients with newly diagnosed metastatic breast cancer

Secondary Outcome Measures

Name	Time	Method
Overall survival	Duration of Study	To estimate overall survival (OS) for each of the 2 treatment arms
Safety	Duration of Study	To compare the tolerability of anastrozole/placebo to that of anastrozole/ZD1839
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
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
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

Trial Locations

Locations (1)

Research Site; 🇻🇪 Valencia, Venezuela