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

NCT ID: NCT01237327

Last Updated: 2011-05-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-11-30

Study Completion Date

2009-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Metastatic Breast Cancer

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type ACTIVE_COMPARATOR

Megestrol acetate

Intervention Type DRUG

Megestrol Acetate 160 mg oral tablets Qd

2

Group Type EXPERIMENTAL

exemestane (Aromasin)

Intervention Type DRUG

exemestane (Aromasin) 25 mg oral tablets Qd

Interventions

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Megestrol acetate

Megestrol Acetate 160 mg oral tablets Qd

Intervention Type DRUG

exemestane (Aromasin)

exemestane (Aromasin) 25 mg oral tablets Qd

Intervention Type DRUG

Other Intervention Names

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Megace Aromasin

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, , China

Site Status

PLA 307 Hospital

Beijing, , China

Site Status

Ba Yi Hospital, Cancer Center of CPLA

Nanjing, , China

Site Status

Jiangsu Cancer Hospital

Nanjing, , China

Site Status

Cancer Hospital

Shanghai, , China

Site Status

The 2nd Central Hospital of Tianjin

Tianjin, , China

Site Status

The 1st Affiliated Hospital, Xi'an Jiao Tong University

Xi'an, , China

Site Status

Countries

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China

Related Links

Other Identifiers

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A5991027

Identifier Type: -

Identifier Source: secondary_id

971-ONC-0028-094

Identifier Type: -

Identifier Source: org_study_id

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