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Completed

NCT Number: NCT00932165

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

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.

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Key information

Conditions

Breast Neoplasms Breast Diseases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Exemestane

Drug

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 names: Aromasin

Primary outcomes

  1. 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).

  2. 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)

  3. 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.

  4. 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.

  5. Number of Post-operative Adjuvant Therapy Participants With Breast Cancer Recurrence Status

    Time frame: 24 weeks

Secondary outcomes

  1. 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).

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Jul 3, 2009
Registry last updated
Jul 20, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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