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Multicenter Follow Up Study Of Subjects Who Participated In An Original Protocol Of Exemestane Vs. Megestrol Acetate In Postmenopausal Women With Metastatic Breast Cancer

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NCT01237327

Last updated on May 9, 2018
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FOR MORE INFORMATION
Study Location
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, , 100021 China
See other locations
Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Metastatic Breast Cancer
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0+
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Previous participation in study 971-ONC-0028-080.

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

- Subjects who had not previously participated in study 971-ONC-0028-080.

NCT01237327
Pfizer
Completed
Multicenter Follow Up Study Of Subjects Who Participated In An Original Protocol Of Exemestane Vs. Megestrol Acetate In Postmenopausal Women With Metastatic Breast Cancer

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Multicenter Follow Up Study Of Subjects Who Participated In An Original Protocol Of Exemestane Vs. Megestrol Acetate In Postmenopausal Women With Metastatic Breast Cancer
Follow-up of the Study 971-ONC-0028-080: Exemestane Versus Megestrol Acetate In Postmenopausal Patients With Metastatic Breast Cancer, Failing Anti-Estrogens: An Open-Label, Randomized, Parallel-Group, Phase III Comparative Study
Long term efficacy of exemestane as compared to megestrol acetate in the treatment of women with natural or induced postmenopausal status with advanced breast cancer whose disease has progressed following anti-estrogens or anti-estrogens plus chemotherapy and who had participated on an original study of exemestane vs megestrol : study 971-ONC-0028-080.
Not Provided
Interventional
Phase 3
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Metastatic Breast Cancer
  • Drug: Megestrol acetate
    Megestrol Acetate 160 mg oral tablets Qd
    Other Name: Megace
  • Drug: exemestane (Aromasin)
    exemestane (Aromasin) 25 mg oral tablets Qd
    Other Name: Aromasin
  • Active Comparator: 1
    Intervention: Drug: Megestrol acetate
  • Experimental: 2
    Intervention: Drug: exemestane (Aromasin)
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
84
December 2009
December 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Previous participation in study 971-ONC-0028-080.

Exclusion Criteria:

  • Subjects who had not previously participated in study 971-ONC-0028-080.
Sexes Eligible for Study: Female
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01237327
971-ONC-0028-094
A5991027
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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