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

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00932165
• Other study ID #: A5991078
• Status: Completed
• Phase: N/A
• First received: June 30, 2009
• Last updated: July 13, 2010
• Start date: December 2004
• Est. completion date: November 2008

Study information

• Verified date: July 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 451
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Subjects with postmenopausal breast cancer (including ovariectomy etc.).

Exclusion Criteria:

• Patients cannot be evaluated.For example, not administered Exemestane (Aromasin).

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Neoplasms
• Liver Diseases

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."

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	No
Primary	Number of Post-operative Adjuvant Therapy Participants With Breast Cancer Recurrence Status		24 weeks	No
Secondary	Number of Participants With Unexpected Adverse Drug Reaction	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).	24 weeks	Yes
Secondary	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	Yes
Secondary	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	Yes

External Links

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