Special Investigation For Patients With Renal And/Or Hepatic Disorders On Aromasin
- Registration Number
- NCT00932165
- Lead Sponsor
- Pfizer
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 451
- Subjects with postmenopausal breast cancer (including ovariectomy etc.).
- Patients cannot be evaluated.For example, not administered Exemestane (Aromasin).
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Exemestane Exemestane Patients taking Exemestane Tablets.
- Primary Outcome Measures
Name Time Method Number of Participants With Factors Considered to Affect the Safety and/or Efficacy of Exemestane 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 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 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 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 24 weeks
- Secondary Outcome Measures
Name Time Method Number of Participants With Unexpected Adverse Drug Reaction 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 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 24 weeks The participants who were diagnosed by the investigator as the participants with renal dysfunction, and observed for safety information.