Special Investigation For Patients With Renal And/Or Hepatic Disorders On Aromasin

• 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: Pfizer
• 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 ]

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

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

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