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
|Condition or disease||Intervention/treatment|
|Breast Neoplasms||Drug: Exemestane|
|Study Type :||Observational|
|Actual Enrollment :||451 participants|
|Official Title:||Special Investigation For Patients With Renal And/Or Hepatic Disorders On Aromasin (Regulatory Post Marketing Commitment Plan)|
|Study Start Date :||December 2004|
|Primary Completion Date :||November 2008|
|Study Completion Date :||November 2008|
Patients taking Exemestane Tablets.
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
- 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 ]
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00932165
|Study Director:||Pfizer CT.gov Call Center||Pfizer|