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

Breast Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00143390
• Other study ID #: A5991048
• Status: Completed
• Phase: Phase 3
• First received: September 1, 2005
• Last updated: December 19, 2011
• Start date: April 2005
• Est. completion date: December 2010

Study information

• Verified date: December 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 298
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

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 Neoplasms

Intervention

Drug:
• exemestane
take orally one tablet per day of exemestane 25 mg and one tablet per day of anastrozole placebo daily after meal
• anastrozole
take orally one tablet of anastrozole 1 mg and one tablet of exemestane placebo daily after meal

Locations

Country	Name	City	State
Japan	Pfizer Investigational Site	Akashi	Hyogo
Japan	Pfizer Investigational Site	Amagasaki	Hyogo
Japan	Pfizer Investigational Site	Anjo	Aichi
Japan	Pfizer Investigational Site	Bunkyo-ku	Tokyo
Japan	Pfizer Investigational Site	Chiba
Japan	Pfizer Investigational Site	Chiyoda-ku	Tokyo
Japan	Pfizer Investigational Site	Chuo-Ku	Tokyo
Japan	Pfizer Investigational Site	Fukuoka
Japan	Pfizer Investigational Site	Hamamatsu	Shizouka
Japan	Pfizer Investigational Site	Higashiibaraki-gun	Ibaraki
Japan	Pfizer Investigational Site	Hiroshima
Japan	Pfizer Investigational Site	Hitachi	Ibaraki
Japan	Pfizer Investigational Site	Iruma-gun	Saitama
Japan	Pfizer Investigational Site	Kagoshima
Japan	Pfizer Investigational Site	Kita-adachi-gun	Saitama
Japan	Pfizer Investigational Site	Kita-Kyushu	Fukuoka
Japan	Pfizer Investigational Site	Kobe	Hyogo
Japan	Pfizer Investigational Site	Koriyama	Fukushima
Japan	Pfizer Investigational Site	Koto-ku	Tokyo
Japan	Pfizer Investigational Site	Kumamoto
Japan	Pfizer Investigational Site	Kurashiki	Okayama
Japan	Pfizer Investigational Site	Kure	Hiroshima
Japan	Pfizer Investigational Site	Kurume	Fukuoka
Japan	Pfizer Investigational Site	Matsuyama	Ehime
Japan	Pfizer Investigational Site	Meguro-ku	Tokyo
Japan	Pfizer Investigational Site	Mitaka	Tokyo
Japan	Pfizer Investigational Site	Morioka	Iwate
Japan	Pfizer Investigational Site	Nagoya	Aichi
Japan	Pfizer Investigational Site	Naha	Okinawa
Japan	Pfizer Investigational Site	Niigata
Japan	Pfizer Investigational Site	Osaka
Japan	Pfizer Investigational Site	Ota	Gunma
Japan	Pfizer Investigational Site	Sagamihara	Kanagawa
Japan	Pfizer Investigational Site	Saitama
Japan	Pfizer Investigational Site	Sakai	Osaka
Japan	Pfizer Investigational Site	Sakura	Chiba
Japan	Pfizer Investigational Site	Sapporo	Hokkaido
Japan	Pfizer Investigational Site	Sendai	Miyagi
Japan	Pfizer Investigational Site	Shimotsuke	Tochigi
Japan	Pfizer Investigational Site	Shizuoka
Japan	Pfizer Investigational Site	Sunto-gun	Shizuoka
Japan	Pfizer Investigational Site	Toyoake	Aichi
Japan	Pfizer Investigational Site	Toyohashi	Aiche
Japan	Pfizer Investigational Site	Toyota	Aichi
Japan	Pfizer Investigational Site	Utsunomiya	Tochigi
Japan	Pfizer Investigational Site	Yokohama	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Progression (TTP) - Expert Evaluation Committee Assessment	Time in months from randomization to first documentation of objective tumor progression or death due to breast cancer, whichever comes first. Tumor progression was determined by the expert evaluation committee using RECIST version 1.0 as an at least a 20% increase in the sum of the longest diameters (SLD) of the target lesions compared to the smallest SLD since the study treatment started. For participants with bone metastasis only, at least 25% increase in the measurable lesion according to General Rules for Clinical and Pathological Study of Breast Cancer (The 14th edition).	Up to 2008 days of the treatment	No
Secondary	Time to Progression (TTP) - Investigators Assessment	Time in months from randomization to first documentation of objective tumor progression or death due to breast cancer, whichever comes first. Tumor progression was determined by the investigator using RECIST version 1.0 as an at least a 20% increase in the sum of the longest diameters (SLD) of the target lesions compared to the smallest SLD since the study treatment started. For participants with bone metastasis only, at least 25% increase in the measurable lesion according to General Rules for Clinical and Pathological Study of Breast Cancer (The 14th edition).	Up to 2008 days of the treatment	No
Secondary	Number of Participants With Objective Response - Investigators Assessment	Number of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST version 1.0). CR and PR are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as the disappearance of all target and nontarget lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters (SLD) of the targeted lesions. Objective Response (OR)= CR + PR.	Up to 2008 days of the treatment	No
Secondary	Number of Participants With Clinical Benefit - Investigator Assessment	Number of participants with clinical benefit based assessment of CR, PR or long-term stable disease (SD) according to the RECIST (version 1.0). CR and PR are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as the disappearance of all target and nontarget lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters (SLD) of the targeted lesions. Long-term SD was defined as SD lasted for at least 24 weeks (168 days). Clinical benefit = CR + PR + long SD	Up to 2008 days of the treatment	No
Secondary	Overall Survival (OS)	OS is defined as time from the date of randomization to the date of death.	Up to 2008 days of the treatment	Yes
Secondary	Time to Treatment Failure (TTF)	TTF is defined as the time from the randomization to the date of the first documentation of progressive disease (PD), symptomatic deterioration, death due to any cause, or treatment discontinuation due to adverse event, refusal or other reasons.	Up to 2008 days of the treatment	Yes

External Links

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