Clinical trial NCT00077025: Comparing Anastrozole-Placebo to the Combination Anastrozole-ZD1839 in Postmenopausal Patients With Estrogen Receptor and/or Progesterone Receptor Metastatic Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: metastatic breast cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2004-02-11
Enrollment: 174
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time to progression
timeFrame: Duration of study
Secondary outcomes:
measure: Objective response rate
timeFrame: Duration of Study
measure: Overall clinical benefit rate
timeFrame: Duration of Study
measure: Overall survival
timeFrame: Duration of Study
measure: Safety
timeFrame: Duration of Study
measure: Pharmacokinetic variables
timeFrame: Duration of Study
measure: Biomarker objectives
timeFrame: Duration of Study
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: Orlando
country: United States
facility: Research Site
state: Florida
city: Lafayette
country: United States
facility: Research Site
state: Louisiana
city: Rockville
country: United States
facility: Research Site
state: Maryland
city: Columbia
country: United States
facility: Research Site
state: Missouri
city: Omaha
country: United States
facility: Research Site
state: Nebraska
city: Las Vegas
country: United States
facility: Research Site
state: Nevada
city: Voorhees
country: United States
facility: Research Site
state: New Jersey
city: Albuquerque
country: United States
facility: Research Site
state: New Mexico
city: Lake Success
country: United States
facility: Research Site
state: New York
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Allentown
country: United States
facility: Research Site
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Research Site
state: South Dakota
city: Houston
country: United States
facility: Research Site
state: Texas
city: Temple
country: United States
facility: Research Site
state: Texas
city: Cali
country: Colombia
facility: Research Site
city: Aguascalientes
country: Mexico
facility: Research Site
city: Guadalajara
country: Mexico
facility: Research Site
city: Morelia
country: Mexico
facility: Research Site
city: Barcelona
country: Venezuela
facility: Research Site
city: Barquisimeto
country: Venezuela
facility: Research Site
city: Caracas
country: Venezuela
facility: Research Site
city: Maracaibo
country: Venezuela
facility: Research Site
city: Puerto Ordaz
country: Venezuela
facility: Research Site
city: San Cristobal
country: Venezuela
facility: Research Site
city: Valencia
country: Venezuela
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Iressa Medical Science Director, MD
role: STUDY_DIRECTOR
References: