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

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Toyohashi, Aiche, Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Neoplasms
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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

NCT00143390
Pfizer
Completed
Aromasin Vs Arimidex Study As Initial Hormonal Therapy In Postmenopausal Women With Advanced/Recurrent Breast Cancer

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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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Sexes Eligible for Study: Female
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00143390
A5991048
Yes
Not Provided
Not Provided
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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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