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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00143390
First received: September 1, 2005
Last updated: December 19, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention Phase
Breast Neoplasms
Drug: exemestane
Drug: anastrozole
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Time to Progression (TTP) - Expert Evaluation Committee Assessment [ Time Frame: Up to 2008 days of the treatment ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Time to Progression (TTP) - Investigators Assessment [ Time Frame: Up to 2008 days of the treatment ] [ Designated as safety issue: No ]
    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).

  • Number of Participants With Objective Response - Investigators Assessment [ Time Frame: Up to 2008 days of the treatment ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Clinical Benefit - Investigator Assessment [ Time Frame: Up to 2008 days of the treatment ] [ Designated as safety issue: No ]
    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

  • Overall Survival (OS) [ Time Frame: Up to 2008 days of the treatment ] [ Designated as safety issue: Yes ]
    OS is defined as time from the date of randomization to the date of death.

  • Time to Treatment Failure (TTF) [ Time Frame: Up to 2008 days of the treatment ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 298
Study Start Date: April 2005
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: exemestane
take orally one tablet per day of exemestane 25 mg and one tablet per day of anastrozole placebo daily after meal
Experimental: 2 Drug: anastrozole
take orally one tablet of anastrozole 1 mg and one tablet of exemestane placebo daily after meal

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00143390

Locations
Japan
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
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00143390     History of Changes
Other Study ID Numbers: A5991048
Study First Received: September 1, 2005
Results First Received: October 12, 2011
Last Updated: December 19, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Anastrozole
Exemestane
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 01, 2014