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

Study Overview
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Brief Summary
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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
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All the patients whom an investigator prescribes the first Exemestane (Aromasin) should be registered.

Official Title
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Special Investigation For Patients With Renal And/Or Hepatic Disorders On Aromasin (Regulatory Post Marketing Commitment Plan)

Conditions
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Breast Neoplasms

Intervention / Treatment
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* Drug: Exemestane


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with postmenopausal breast cancer (including ovariectomy etc.). Exclusion Criteria: Patients cannot be evaluated.For example, not administered Exemestane (Aromasin).
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Exemestane<br>Patients taking Exemestane Tablets. | Drug: Exemestane<br>* 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.<br>* Other names: Aromasin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Factors Considered to Affect the Safety and/or Efficacy of Exemestane | 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). | 24 weeks | 
| 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 | 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) | 24 weeks | 
| Number of Participants With Adverse Drug Reaction | 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. | 24 weeks | 
| Number of Tumor Responders in Progressive Breast Cancer or Recurrent Breast Cancer to Exemestane Treatment | 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. | 24 weeks | 
| Number of Post-operative Adjuvant Therapy Participants With Breast Cancer Recurrence Status |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Unexpected Adverse Drug Reaction | Adverse drug reaction that is not included in the precautions for useor undesirable effects section in the package insert (same as Local Product Document). | 24 weeks | 
| Number of Participants With Adverse Drug Reaction for Subjects With Hepatic Dysfunction | The participants who were diagnosed by the investigator as the participants with hepatic dysfunction, and observed for safety information. | 24 weeks | 
| Number of Participants With Adverse Drug Reaction for Subjects With Renal Dysfunction | The participants who were diagnosed by the investigator as the participants with renal dysfunction, and observed for safety information. | 24 weeks |