Aromasin Vs Arimidex Study As Initial Hormonal Therapy In Postmenopausal Women With Advanced/Recurrent Breast Cancer
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00143390
First received: September 1, 2005
Last updated: December 19, 2011
Last verified: December 2011
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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
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 Neoplasms by Site Breast Diseases Skin Diseases Exemestane Anastrozole |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Aromatase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Hormonal |
ClinicalTrials.gov processed this record on May 16, 2013