Multicenter Follow Up Study Of Subjects Who Participated In An Original Protocol Of Exemestane Vs. Megestrol Acetate In Postmenopausal Women With Metastatic Breast Cancer
Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Metastatic Breast Cancer
Intervention: Megestrol acetate (Drug); exemestane (Aromasin) (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Pfizer Official(s) and/or principal investigator(s): Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Summary
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.
Clinical Details
Official title: 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
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Overall Survival
Secondary outcome: Objective Response Rate (ORR)Duration of Response (DR) Time to Tumor Progression (TTP) Time to Treatment Failure (TTF)
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Previous participation in study 971-ONC-0028-080.
Exclusion Criteria:
- Subjects who had not previously participated in study 971-ONC-0028-080.
Locations and Contacts
Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing 100021, China
PLA 307 Hospital, Beijing 100039, China
Ba Yi Hospital, Cancer Center of CPLA, Nanjing 210002, China
Jiangsu Cancer Hospital, Nanjing 210009, China
Cancer Hospital, Shanghai 200032, China
The 2nd Central Hospital of Tianjin, Tianjin 300120, China
The 1st Affiliated Hospital, Xi'an Jiao Tong University, Xi'an 710061, China
Additional Information
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Starting date: November 2001
Last updated: May 3, 2011
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