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

September 1, 2005
December 19, 2011
April 2005
December 2010   (final data collection date for primary outcome measure)
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).
Time to tumor progression (TTP): defined as time from randomization to the date of confirmation of progressive disease (PD) or breast cancer death.
Complete list of historical versions of study NCT00143390 on ClinicalTrials.gov Archive Site
  • 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.
Response rate is defined as the proportion of patients achieving complete remission (CR) or partial remission (PR) in the analysis sets defied according to RECIST criteria. [Patients having a bone lesion to be measurable in two dimensions or non-measurab
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Breast Neoplasms
  • Drug: exemestane
    take orally one tablet per day of exemestane 25 mg and one tablet per day of anastrozole placebo daily after meal
  • Drug: anastrozole
    take orally one tablet of anastrozole 1 mg and one tablet of exemestane placebo daily after meal
  • Experimental: 1
    Intervention: Drug: exemestane
  • Experimental: 2
    Intervention: Drug: anastrozole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
298
December 2010
December 2010   (final data collection date for primary outcome measure)

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
Female
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00143390
A5991048
Yes
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP