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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

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

To obtain contact information for a study center near you, click here.

Starting date: November 2001
Last updated: May 3, 2011

Page last updated: August 23, 2015

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