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

May 3, 2011 updated by: Pfizer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100021
        • Cancer Institute and Hospital, Chinese Academy of Medical Sciences
      • Beijing, China, 100039
        • PLA 307 Hospital
      • Nanjing, China, 210009
        • Jiangsu Cancer Hospital
      • Nanjing, China, 210002
        • Ba Yi Hospital, Cancer Center of CPLA
      • Shanghai, China, 200032
        • Cancer Hospital
      • Tianjin, China, 300120
        • The 2nd Central Hospital of Tianjin
      • Xi'an, China, 710061
        • The 1st Affiliated Hospital, Xi'an Jiao Tong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 2
Drug: exemestane (Aromasin)
exemestane (Aromasin) 25 mg oral tablets Qd
Other Names:
  • Aromasin
Active Comparator: 1
Drug: Megestrol acetate
Megestrol Acetate 160 mg oral tablets Qd
Other Names:
  • Megace

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: Every 12 weeks up to 6 years
Overall survival in months measured from date of starting treatment in core study to date of death for any reason.
Every 12 weeks up to 6 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: Every 12 weeks up to 6 years
Percentage of participants achieving an objective response (OR) defined as complete response (CR) or partial response (PR) out of the total number of participants randomized in each treatment group
Every 12 weeks up to 6 years
Duration of Response (DR)
Time Frame: Every 12 weeks up to 6 years
Duration of objective response (complete response [CR] or partial response [PR]) calculated from date objective response was first documented to date of progressive disease. For subjects proceeding from PR to CR, the onset of PR was taken as the onset of objective response.
Every 12 weeks up to 6 years
Time to Tumor Progression (TTP)
Time Frame: Every 12 weeks up to 6 years
TTP = time between first day of study treatment and date of documented disease progression, or date of tumor-related death in the absence of previously documented progressive disease (PD). PD defined as a 25% or greater increase in size of 1 or more lesions compared to smallest previous assessment, or appearance of new lesion, or unequivocal worsening of bone lesions, or progression of nonevaluable lesions.
Every 12 weeks up to 6 years
Time to Treatment Failure (TTF)
Time Frame: Every 12 weeks up to 6 years
TTF = time between first day of study treatment and date of diagnosis of progression, withdrawal from study treatment for any reason, administration of other antitumor treatment, or death from any cause, whichever was the earliest event.
Every 12 weeks up to 6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2001

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

November 3, 2010

First Submitted That Met QC Criteria

November 5, 2010

First Posted (Estimate)

November 9, 2010

Study Record Updates

Last Update Posted (Estimate)

May 6, 2011

Last Update Submitted That Met QC Criteria

May 3, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 971-ONC-0028-094
  • A5991027

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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