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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00932165
First received: June 30, 2009
Last updated: July 13, 2010
Last verified: July 2010
  Purpose

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.


Condition Intervention
Breast Neoplasms
Drug: Exemestane

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Special Investigation For Patients With Renal And/Or Hepatic Disorders On Aromasin (Regulatory Post Marketing Commitment Plan)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Participants With Factors Considered to Affect the Safety and/or Efficacy of Exemestane [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Participants With Unexpected Adverse Drug Reaction [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    The participants who were diagnosed by the investigator as the participants with renal dysfunction, and observed for safety information.


Enrollment: 451
Study Start Date: December 2004
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Exemestane
Patients taking Exemestane Tablets.
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."
Other Name: Aromasin

Detailed Description:

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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The patients whom an investigator involving A5991078 prescribes the Exemestane (Aromasin).

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients cannot be evaluated.For example, not administered Exemestane (Aromasin).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00932165

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00932165     History of Changes
Other Study ID Numbers: A5991078
Study First Received: June 30, 2009
Results First Received: November 13, 2009
Last Updated: July 13, 2010
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Breast Neoplasms
Liver Diseases
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Digestive System Diseases
Exemestane
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014