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

Phase 3

Completed

• Conditions: Breast Neoplasms
• Interventions: Drug: exemestane; Drug: anastrozole

• Registration Number: NCT00143390
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2005-09-01
• Study First Submitted QC: 2005-09-01
• Study First Posted: 2005-09-02
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Results First Submitted: 2011-10-12
• Status Verified: 2011-12
• Results First Submitted QC: 2011-12-19
• Last Update Submitted: 2011-12-19
• Results First Posted: 2012-01-25
• Last Update Posted: 2012-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 298

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	exemestane	-
2	anastrozole	-

Primary Outcome Measures

Name	Time	Method
Time to Progression (TTP) - Expert Evaluation Committee Assessment	Up to 2008 days of the treatment	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

Name	Time	Method
Time to Progression (TTP) - Investigators Assessment	Up to 2008 days of the treatment	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	Up to 2008 days of the treatment	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	Up to 2008 days of the treatment	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)	Up to 2008 days of the treatment	OS is defined as time from the date of randomization to the date of death.
Time to Treatment Failure (TTF)	Up to 2008 days of the treatment	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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇯🇵 Shizuoka, Japan