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

Breast Cancer Clinical Trial

Official title:

Phase II Multicenter, Double-Blind, Randomized Trial Comparing Anastrozole (ZD1033, Arimidex™)-Placebo to the Combination Anastrozole-ZD1839 (Gefitinib, IRESSA™) in Postmenopausal Patients With Estrogen Receptor (ER) and/or Progesterone Receptor (PgR) Metastatic Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00077025
• Other study ID #: 1839US/0713
• Status: Completed
• Phase: Phase 2
• First received: February 9, 2004
• Last updated: July 15, 2014
• Start date: January 2004
• Est. completion date: May 2013

Study information

• Verified date: July 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Gefitinib
ZD1839 (gefitinib, IRESSA) 250 mg/DAY PO + 1 mg Anastrozole (ZD1033, Arimidex)
• Anastrozole
1 mg Anastrozole (ZD1033, Arimidex) + PLACEBO 1 TABLET/DAY PO

Locations

Country	Name	City	State
Colombia	Research Site	Cali
Mexico	Research Site	Aguascalientes
Mexico	Research Site	Guadalajara
Mexico	Research Site	Morelia
United States	Research Site	Albuquerque	New Mexico
United States	Research Site	Allentown	Pennsylvania
United States	Research Site	Cincinnati	Ohio
United States	Research Site	Columbia	Missouri
United States	Research Site	Houston	Texas
United States	Research Site	La Jolla	California
United States	Research Site	Lafayette	Louisiana
United States	Research Site	Lake Success	New York
United States	Research Site	Las Vegas	Nevada
United States	Research Site	Omaha	Nebraska
United States	Research Site	Orlando	Florida
United States	Research Site	Rockville	Maryland
United States	Research Site	San Diego	California
United States	Research Site	Sioux Falls	South Dakota
United States	Research Site	Temple	Texas
United States	Research Site	Voorhees	New Jersey
Venezuela	Research Site	Barcelona
Venezuela	Research Site	Barquisimeto
Venezuela	Research Site	Caracas
Venezuela	Research Site	Maracaibo
Venezuela	Research Site	Puerto Ordaz
Venezuela	Research Site	San Cristobal
Venezuela	Research Site	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Venezuela,  Colombia,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to progression	To estimate TTP in the 2 treatment arms of postmenopausal patients with newly diagnosed metastatic breast cancer	Duration of study	No
Secondary	Objective response rate	To estimate the ORR (complete response [CR] and partial response [PR] as defined by RECIST for the 2 treatment arms	Duration of Study	No
Secondary	Overall clinical benefit rate	To estimate the clinical benefit rates (CBR; defined as CR+PR[as per RECIST]+stable disease [SD]>24 weeks) for the 2 treatment arms	Duration of Study	No
Secondary	Overall survival	To estimate overall survival (OS) for each of the 2 treatment arms	Duration of Study	No
Secondary	Safety	To compare the tolerability of anastrozole/placebo to that of anastrozole/ZD1839	Duration of Study	Yes
Secondary	Pharmacokinetic variables	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	Duration of Study	No
Secondary	Biomarker objectives	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	Duration of Study	No

External Links

•   Cancer Study Locator (US and Canada only)
•   CSR-1839US-0713.pdf