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
|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|
|Actual Primary Completion Date :||November 2008|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00932165
|Study Director:||Pfizer CT.gov Call Center||Pfizer|