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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01237327
First received: November 3, 2010
Last updated: May 3, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention Phase
Metastatic Breast Cancer
Drug: Megestrol acetate
Drug: exemestane (Aromasin)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: Every 12 weeks up to 6 years ] [ Designated as safety issue: No ]
    Overall survival in months measured from date of starting treatment in core study to date of death for any reason.


Secondary Outcome Measures:
  • Objective Response Rate (ORR) [ Time Frame: Every 12 weeks up to 6 years ] [ Designated as safety issue: No ]
    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

  • Duration of Response (DR) [ Time Frame: Every 12 weeks up to 6 years ] [ Designated as safety issue: No ]
    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.

  • Time to Tumor Progression (TTP) [ Time Frame: Every 12 weeks up to 6 years ] [ Designated as safety issue: No ]
    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.

  • Time to Treatment Failure (TTF) [ Time Frame: Every 12 weeks up to 6 years ] [ Designated as safety issue: No ]
    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.


Enrollment: 84
Study Start Date: November 2001
Study Completion Date: December 2009
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: Megestrol acetate
Megestrol Acetate 160 mg oral tablets Qd
Other Name: Megace
Experimental: 2 Drug: exemestane (Aromasin)
exemestane (Aromasin) 25 mg oral tablets Qd
Other Name: Aromasin

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01237327

Locations
China
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, China, 100021
PLA 307 Hospital
Beijing, China, 100039
Jiangsu Cancer Hospital
Nanjing, China, 210009
Ba Yi Hospital, Cancer Center of CPLA
Nanjing, China, 210002
Cancer Hospital
Shanghai, China, 200032
The 2nd Central Hospital of Tianjin
Tianjin, China, 300120
The 1st Affiliated Hospital, Xi'an Jiao Tong University
Xi'an, China, 710061
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01237327     History of Changes
Other Study ID Numbers: 971-ONC-0028-094, A5991027
Study First Received: November 3, 2010
Results First Received: December 7, 2010
Last Updated: May 3, 2011
Health Authority: China: Ministry of Health

Keywords provided by Pfizer:
Metastatic Breast Cancer
Advanced
Postmenopausal
Exemestane vs Megestrol

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Megestrol
Megestrol Acetate
Exemestane
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Appetite Stimulants
Central Nervous System Stimulants
Central Nervous System Agents
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 18, 2014