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Trial record 1 of 1 for:    NCT00932165
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Special Investigation For Patients With Renal And/Or Hepatic Disorders On Aromasin

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ClinicalTrials.gov Identifier: NCT00932165
Recruitment Status : Completed
First Posted : July 3, 2009
Results First Posted : June 24, 2010
Last Update Posted : July 20, 2010
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date June 30, 2009
First Posted Date July 3, 2009
Results First Submitted Date November 13, 2009
Results First Posted Date June 24, 2010
Last Update Posted Date July 20, 2010
Study Start Date December 2004
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 13, 2010)
  • Number of Participants With Factors Considered to Affect the Safety and/or Efficacy of Exemestane [ Time Frame: 24 weeks ]
    Assessment of factors likely to affect the safety and/or efficacy: reason for Exemestane use (primary progressive breast cancer, relapsed breast cancer or postoperative adjuvant therapy)and past history (presence or absence of at least one disease).
  • Number of Participants With Performance Status Score Based on Eastern Cooperative Oncology Group (ECOG) Factors Considered to Affect the Safety and/or Efficacy of Exemestane [ Time Frame: 24 weeks ]
    Scale 0; Asymptomatic (Fully active, able to carry on all predisease activities without restriction), 1; Symptomatic but completely ambulatory (Restricted in physically strenuous activity ,ambulatory and able to carry out light or sedentary work), 2 ; Symptomatic, <50% in bed during the day (Ambulatory,capable of all self care, unable to carry out any work activities., 3; Symptomatic, >50% in bed, not bedbound (Capable of only limited self-care, confined to bed or chair 50% or more waking hours), 4; Bedbound (Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair)
  • Number of Participants With Adverse Drug Reaction [ Time Frame: 24 weeks ]
    Confirmation of the number of subjects with treatment related adverse events. All adverse events regardless of causal relationship with Aromasin Tablet at the end of observation period was reported.
  • Number of Tumor Responders in Progressive Breast Cancer or Recurrent Breast Cancer to Exemestane Treatment [ Time Frame: 24 weeks ]
    Anti-tumor effect was evaluated according to the rules for 'General Rules for Clinical and Pathological Recording of Breast Cancer' (the 15th edition)/Response Evaluation Criteria in Solid Tumors (RECIST) Guideline. Judged as Completed response (CR) or partial response (PR), stable disease (SD) or progressive disease (PD) after the treatment start.
  • Number of Post-operative Adjuvant Therapy Participants With Breast Cancer Recurrence Status [ Time Frame: 24 weeks ]
Original Primary Outcome Measures
 (submitted: July 2, 2009)
  • Adverse drug reaction not expected from the LPD (unknown adverse drug reaction). [ Time Frame: 24 weeks ]
  • Factors considered to affect the safety and/or efficacy of this drug. [ Time Frame: 24 weeks ]
  • The incidence of adverse drug reactions in this surveillance. [ Time Frame: 24 weeks ]
Change History
Current Secondary Outcome Measures
 (submitted: May 25, 2010)
  • Number of Participants With Unexpected Adverse Drug Reaction [ Time Frame: 24 weeks ]
    Adverse drug reaction that is not included in the "precautions for use"or "undesirable effects" section in the package insert (same as Local Product Document).
  • Number of Participants With Adverse Drug Reaction for Subjects With Hepatic Dysfunction [ Time Frame: 24 weeks ]
    The participants who were diagnosed by the investigator as the participants with hepatic dysfunction, and observed for safety information.
  • Number of Participants With Adverse Drug Reaction for Subjects With Renal Dysfunction [ Time Frame: 24 weeks ]
    The participants who were diagnosed by the investigator as the participants with renal dysfunction, and observed for safety information.
Original Secondary Outcome Measures
 (submitted: July 2, 2009)
Follow up for safety information about the patients with hepatic dysfunction or renal dysfunction. [ Time Frame: 1 year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Special Investigation For Patients With Renal And/Or Hepatic Disorders On Aromasin
Official Title Special Investigation For Patients With Renal And/Or Hepatic Disorders On Aromasin (Regulatory Post Marketing Commitment Plan)
Brief Summary The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.
Detailed Description All the patients whom an investigator prescribes the first Exemestane (Aromasin) should be registered.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population The patients whom an investigator involving A5991078 prescribes the Exemestane (Aromasin).
Condition Breast Neoplasms
Intervention Drug: Exemestane
Aromasin® Tablets 25mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. " The usual adult dose is 25 mg of exemestane administered orally once daily after a meal."
Other Name: Aromasin
Study Groups/Cohorts Exemestane
Patients taking Exemestane Tablets.
Intervention: Drug: Exemestane
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 Completed
Actual Enrollment
 (submitted: May 25, 2010)
451
Original Actual Enrollment
 (submitted: July 2, 2009)
450
Actual Study Completion Date November 2008
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Subjects with postmenopausal breast cancer (including ovariectomy etc.).

Exclusion Criteria:

  • Patients cannot be evaluated.For example, not administered Exemestane (Aromasin).
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00932165
Other Study ID Numbers A5991078
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date July 2010