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

NCT00932165 | Completed Results

• 1 other identifier: A5991078
• Study Type: observational
• Target: 451
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Number of Participants With Unexpected Adverse Drug Reaction

  24 weeks

• Number of Participants With Adverse Drug Reaction for Subjects With Hepatic Dysfunction

  24 weeks

• Number of Participants With Adverse Drug Reaction for Subjects With Renal Dysfunction

  24 weeks

Study Arms (1)

Exemestane

Patients taking Exemestane Tablets.

Drug: Exemestane

Interventions

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."

Also known as: Aromasin

Exemestane

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Pfizer: lead

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Breast Neoplasms

Interventions

exemestane

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 30, 2009
• First Posted: July 3, 2009
• Study Start: December 1, 2004
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: July 20, 2010
• Results First Posted: June 24, 2010

Record last verified: 2010-07