Clinical trial NCT00143390: Aromasin Vs Arimidex Study As Initial Hormonal Therapy In Postmenopausal Women With Advanced/Recurrent Breast Cancer
Official title: A Randomized, Double-Blind, Controlled Study Of Exemestane (Aromasin) Vs Anastrozole (Arimidex) As Initial Hormonal Therapy In Postmenopausal Women With Advanced/Recurrent Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Neoplasms
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-02
Enrollment: 298
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To verify the non-inferiority of exemestane compared to anastrozole in time to tumor progression (TTP), the primary efficacy endpoint, in postmenopausal women with advanced/recurrent breast cancer.


Eligibility criteria: Inclusion Criteria:

* Have histologically or cytologically confirmed breast cancer at original diagnosis. At study entry, the patient must have metastatic progressive or locally recurrent inoperable breast cancer.

Exclusion Criteria:

* Having received any hormonal therapy (e.g., Tamoxifen, LHRH-agonists) ovariectomy or any chemotherapy for advanced/recurrent breast cancer

Primary outcomes:
measure: Time to Progression (TTP) - Expert Evaluation Committee Assessment
timeFrame: Up to 2008 days of the treatment
Secondary outcomes:
measure: Time to Progression (TTP) - Investigators Assessment
timeFrame: Up to 2008 days of the treatment
measure: Number of Participants With Objective Response - Investigators Assessment
timeFrame: Up to 2008 days of the treatment
measure: Number of Participants With Clinical Benefit - Investigator Assessment
timeFrame: Up to 2008 days of the treatment
measure: Overall Survival (OS)
timeFrame: Up to 2008 days of the treatment
measure: Time to Treatment Failure (TTF)
timeFrame: Up to 2008 days of the treatment
Other outcomes:
Locations:
city: Toyohashi
country: Japan
facility: Pfizer Investigational Site
state: Aiche
city: Anjo
country: Japan
facility: Pfizer Investigational Site
state: Aichi
city: Nagoya
country: Japan
facility: Pfizer Investigational Site
state: Aichi
city: Toyoake
country: Japan
facility: Pfizer Investigational Site
state: Aichi
city: Toyota
country: Japan
facility: Pfizer Investigational Site
state: Aichi
city: Sakura
country: Japan
facility: Pfizer Investigational Site
state: Chiba
city: Matsuyama
country: Japan
facility: Pfizer Investigational Site
state: Ehime
city: Kita-Kyushu
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka
city: Kurume
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka
city: Koriyama
country: Japan
facility: Pfizer Investigational Site
state: Fukushima
city: Ota
country: Japan
facility: Pfizer Investigational Site
state: Gunma
city: Kure
country: Japan
facility: Pfizer Investigational Site
state: Hiroshima
city: Sapporo
country: Japan
facility: Pfizer Investigational Site
state: Hokkaido
city: Akashi
country: Japan
facility: Pfizer Investigational Site
state: Hyogo
city: Amagasaki
country: Japan
facility: Pfizer Investigational Site
state: Hyogo
city: Kobe
country: Japan
facility: Pfizer Investigational Site
state: Hyogo
city: Higashiibaraki-gun
country: Japan
facility: Pfizer Investigational Site
state: Ibaraki
city: Hitachi
country: Japan
facility: Pfizer Investigational Site
state: Ibaraki
city: Morioka
country: Japan
facility: Pfizer Investigational Site
state: Iwate
city: Sagamihara
country: Japan
facility: Pfizer Investigational Site
state: Kanagawa
city: Yokohama
country: Japan
facility: Pfizer Investigational Site
state: Kanagawa
city: Sendai
country: Japan
facility: Pfizer Investigational Site
state: Miyagi
city: Kurashiki
country: Japan
facility: Pfizer Investigational Site
state: Okayama
city: Naha
country: Japan
facility: Pfizer Investigational Site
state: Okinawa
city: Sakai
country: Japan
facility: Pfizer Investigational Site
state: Osaka
city: Iruma-gun
country: Japan
facility: Pfizer Investigational Site
state: Saitama
city: Kita-adachi-gun
country: Japan
facility: Pfizer Investigational Site
state: Saitama
city: Hamamatsu
country: Japan
facility: Pfizer Investigational Site
state: Shizouka
city: Sunto-gun
country: Japan
facility: Pfizer Investigational Site
state: Shizuoka
city: Shimotsuke
country: Japan
facility: Pfizer Investigational Site
state: Tochigi
city: Utsunomiya
country: Japan
facility: Pfizer Investigational Site
state: Tochigi
city: Bunkyo-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Chiyoda-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Chuo-Ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Koto-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Meguro-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Mitaka
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Chiba
country: Japan
facility: Pfizer Investigational Site
city: Fukuoka
country: Japan
facility: Pfizer Investigational Site
city: Hiroshima
country: Japan
facility: Pfizer Investigational Site
city: Kagoshima
country: Japan
facility: Pfizer Investigational Site
city: Kumamoto
country: Japan
facility: Pfizer Investigational Site
city: Niigata
country: Japan
facility: Pfizer Investigational Site
city: Osaka
country: Japan
facility: Pfizer Investigational Site
city: Saitama
country: Japan
facility: Pfizer Investigational Site
city: Shizuoka
country: Japan
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: