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

NCT00143390 | Completed Phase 3 Results DMC

• 1 other identifier: A5991048
• Study Type: interventional
• Target: 298
• Locations: 1 country
• Sites: 47

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.

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Time to Progression (TTP) - Investigators Assessment

  Up to 2008 days of the treatment

• Number of Participants With Objective Response - Investigators Assessment

  Up to 2008 days of the treatment

• Number of Participants With Clinical Benefit - Investigator Assessment

  Up to 2008 days of the treatment

• Overall Survival (OS)

  Up to 2008 days of the treatment

• Time to Treatment Failure (TTF)

  Up to 2008 days of the treatment

Study Arms (2)

1

EXPERIMENTAL

Drug: exemestane

2

EXPERIMENTAL

Drug: anastrozole

Interventions

exemestane DRUG

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

1

anastrozole DRUG

take orally one tablet of anastrozole 1 mg and one tablet of exemestane placebo daily after meal

2

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Having received any hormonal therapy (e.g., Tamoxifen, LHRH-agonists) ovariectomy or any chemotherapy for advanced/recurrent breast cancer

Sponsors & Collaborators

• Pfizer: lead

Study Sites (47)

Pfizer Investigational Site

Toyohashi, Aiche, Japan

Location

Pfizer Investigational Site

Anjo, Aichi-ken, Japan

Location

Pfizer Investigational Site

Nagoya, Aichi-ken, Japan

Location

Pfizer Investigational Site

Toyoake, Aichi-ken, Japan

Location

Pfizer Investigational Site

Toyota, Aichi-ken, Japan

Location

Pfizer Investigational Site

Chiba, Chiba, Japan

Location

Pfizer Investigational Site

Sakura, Chiba, Japan

Location

Pfizer Investigational Site

Matsuyama, Ehime, Japan

Location

Pfizer Investigational Site

Fukuoka, Fukuoka, Japan

Location

Pfizer Investigational Site

Kitakyushu, Fukuoka, Japan

Location

Pfizer Investigational Site

Kurume, Fukuoka, Japan

Location

Pfizer Investigational Site

Kōriyama, Fukushima, Japan

Location

Pfizer Investigational Site

Ōta, Gunma, Japan

Location

Pfizer Investigational Site

Hiroshima, Hiroshima, Japan

Location

Pfizer Investigational Site

Kure, Hiroshima, Japan

Location

Pfizer Investigational Site

Sapporo, Hokkaido, Japan

Location

Pfizer Investigational Site

Akashi, Hyōgo, Japan

Location

Pfizer Investigational Site

Amagasaki, Hyōgo, Japan

Location

Pfizer Investigational Site

Kobe, Hyōgo, Japan

Location

Pfizer Investigational Site

Higashiibaraki-gun, Ibaraki, Japan

Location

Pfizer Investigational Site

Hitachi, Ibaraki, Japan

Location

Pfizer Investigational Site

Morioka, Iwate, Japan

Location

Pfizer Investigational Site

Kagoshima, Kagoshima-ken, Japan

Location

Pfizer Investigational Site

Sagamihara, Kanagawa, Japan

Location

Pfizer Investigational Site

Yokohama, Kanagawa, Japan

Location

Pfizer Investigational Site

Kumamoto, Kumamoto, Japan

Location

Pfizer Investigational Site

Sendai, Miyagi, Japan

Location

Pfizer Investigational Site

Niigata, Niigata, Japan

Location

Pfizer Investigational Site

Kurashiki, Okayama-ken, Japan

Location

Pfizer Investigational Site

Naha, Okinawa, Japan

Location

Pfizer Investigational Site

Osaka, Osaka, Japan

Location

Pfizer Investigational Site

Sakai, Osaka, Japan

Location

Pfizer Investigational Site

Iruma-gun, Saitama, Japan

Location

Pfizer Investigational Site

Kita-adachi-gun, Saitama, Japan

Location

Pfizer Investigational Site

Saitama, Saitama, Japan

Location

Pfizer Investigational Site

Hamamatsu, Shizouka, Japan

Location

Pfizer Investigational Site

Shizuoka, Shizuoka, Japan

Location

Pfizer Investigational Site

Sunto-gun, Shizuoka, Japan

Location

Pfizer Investigational Site

Shimotsuke, Tochigi, Japan

Location

Pfizer Investigational Site

Utsunomiya, Tochigi, Japan

Location

Pfizer Investigational Site

Bunkyo-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Chiyoda-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Chuo-Ku, Tokyo, Japan

Location

Pfizer Investigational Site

Koto-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Meguro-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Mitaka, Tokyo, Japan

Location

Pfizer Investigational Site

Chiba, Japan

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

exemestane; Anastrozole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2005
• First Posted: September 2, 2005
• Study Start: April 1, 2005
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: January 25, 2012
• Results First Posted: January 25, 2012

Record last verified: 2011-12

Locations

JP (47)