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Trial record 1 of 1 for:    NCT01237327
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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01237327
Recruitment Status : Completed
First Posted : November 9, 2010
Results First Posted : March 14, 2011
Last Update Posted : May 6, 2011
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE November 3, 2010
First Posted Date  ICMJE November 9, 2010
Results First Submitted Date  ICMJE December 7, 2010
Results First Posted Date  ICMJE March 14, 2011
Last Update Posted Date May 6, 2011
Study Start Date  ICMJE November 2001
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 17, 2011)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 5, 2010)
Overall Survival [ Time Frame: up to 6 yrs ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 17, 2011)
  • 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
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2010)
  • Objective Response Rate (ORR) [ Time Frame: up to 6 yrs ]
  • Duration of Response (DR) [ Time Frame: up to 6 yrs ]
  • Time to Tumor Progression (TTP) [ Time Frame: up to 6 yrs ]
  • Time to Treatment Failure (TTF) [ Time Frame: up to 6 yrs ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multicenter Follow Up Study Of Subjects Who Participated In An Original Protocol Of Exemestane Vs. Megestrol Acetate In Postmenopausal Women With Metastatic Breast Cancer
Official Title  ICMJE 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
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Breast Cancer
Intervention  ICMJE
  • Drug: Megestrol acetate
    Megestrol Acetate 160 mg oral tablets Qd
    Other Name: Megace
  • Drug: exemestane (Aromasin)
    exemestane (Aromasin) 25 mg oral tablets Qd
    Other Name: Aromasin
Study Arms  ICMJE
  • Active Comparator: 1
    Intervention: Drug: Megestrol acetate
  • Experimental: 2
    Intervention: Drug: exemestane (Aromasin)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 5, 2010)
84
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date December 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Subjects who had not previously participated in study 971-ONC-0028-080.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01237327
Other Study ID Numbers  ICMJE 971-ONC-0028-094
A5991027
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP