Aromasin Vs Arimidex Study As Initial Hormonal Therapy In Postmenopausal Women With Advanced/Recurrent Breast Cancer

A Randomized, Double-Blind, Controlled Study Of Exemestane (Aromasin) Vs Anastrozole (Arimidex) As Initial Hormonal Therapy In Postmenopausal Women With Advanced/Recurrent Breast Cancer

Sponsors

Lead Sponsor: Pfizer

Source Pfizer
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.

Overall Status Completed
Start Date April 2005
Completion Date December 2010
Primary Completion Date December 2010
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Time to Progression (TTP) - Expert Evaluation Committee Assessment Up to 2008 days of the treatment
Secondary Outcome
Measure Time Frame
Time to Progression (TTP) - Investigators Assessment Up to 2008 days of the treatment
Number of Participants With Objective Response - Investigators Assessment Up to 2008 days of the treatment
Number of Participants With Clinical Benefit - Investigator Assessment Up to 2008 days of the treatment
Overall Survival (OS) Up to 2008 days of the treatment
Time to Treatment Failure (TTF) Up to 2008 days of the treatment
Enrollment 298
Condition
Intervention

Intervention Type: Drug

Intervention Name: exemestane

Description: take orally one tablet per day of exemestane 25 mg and one tablet per day of anastrozole placebo daily after meal

Arm Group Label: 1

Intervention Type: Drug

Intervention Name: anastrozole

Description: take orally one tablet of anastrozole 1 mg and one tablet of exemestane placebo daily after meal

Arm Group Label: 2

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

Gender: Female

Minimum Age: 20 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Pfizer CT.gov Call Center Study Director Pfizer
Location
Facility:
Pfizer Investigational Site | Toyohashi, Aiche, Japan
Pfizer Investigational Site | Anjo, Aichi, Japan
Pfizer Investigational Site | Nagoya, Aichi, Japan
Pfizer Investigational Site | Toyoake, Aichi, Japan
Pfizer Investigational Site | Toyota, Aichi, Japan
Pfizer Investigational Site | Sakura, Chiba, Japan
Pfizer Investigational Site | Matsuyama, Ehime, Japan
Pfizer Investigational Site | Kita-Kyushu, Fukuoka, Japan
Pfizer Investigational Site | Kurume, Fukuoka, Japan
Pfizer Investigational Site | Koriyama, Fukushima, Japan
Pfizer Investigational Site | Ota, Gunma, Japan
Pfizer Investigational Site | Kure, Hiroshima, Japan
Pfizer Investigational Site | Sapporo, Hokkaido, Japan
Pfizer Investigational Site | Akashi, Hyogo, Japan
Pfizer Investigational Site | Amagasaki, Hyogo, Japan
Pfizer Investigational Site | Kobe, Hyogo, Japan
Pfizer Investigational Site | Higashiibaraki-gun, Ibaraki, Japan
Pfizer Investigational Site | Hitachi, Ibaraki, Japan
Pfizer Investigational Site | Morioka, Iwate, Japan
Pfizer Investigational Site | Sagamihara, Kanagawa, Japan
Pfizer Investigational Site | Yokohama, Kanagawa, Japan
Pfizer Investigational Site | Sendai, Miyagi, Japan
Pfizer Investigational Site | Kurashiki, Okayama, Japan
Pfizer Investigational Site | Naha, Okinawa, Japan
Pfizer Investigational Site | Sakai, Osaka, Japan
Pfizer Investigational Site | Iruma-gun, Saitama, Japan
Pfizer Investigational Site | Kita-adachi-gun, Saitama, Japan
Pfizer Investigational Site | Hamamatsu, Shizouka, Japan
Pfizer Investigational Site | Sunto-gun, Shizuoka, Japan
Pfizer Investigational Site | Shimotsuke, Tochigi, Japan
Pfizer Investigational Site | Utsunomiya, Tochigi, Japan
Pfizer Investigational Site | Bunkyo-ku, Tokyo, Japan
Pfizer Investigational Site | Chiyoda-ku, Tokyo, Japan
Pfizer Investigational Site | Chuo-Ku, Tokyo, Japan
Pfizer Investigational Site | Koto-ku, Tokyo, Japan
Pfizer Investigational Site | Meguro-ku, Tokyo, Japan
Pfizer Investigational Site | Mitaka, Tokyo, Japan
Pfizer Investigational Site | Chiba, Japan
Pfizer Investigational Site | Fukuoka, Japan
Pfizer Investigational Site | Hiroshima, Japan
Pfizer Investigational Site | Kagoshima, Japan
Pfizer Investigational Site | Kumamoto, Japan
Pfizer Investigational Site | Niigata, Japan
Pfizer Investigational Site | Osaka, Japan
Pfizer Investigational Site | Saitama, Japan
Pfizer Investigational Site | Shizuoka, Japan
Location Countries

Japan

Verification Date

December 2011

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: 1

Type: Experimental

Label: 2

Type: Experimental

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Double (Participant, Investigator)

Source: ClinicalTrials.gov