Research Of Quality Of Life And Safety Outcomes Of Postmenopausal Breast Cancer Patients Switching From Tamoxifen Therapy To Aromatase Inhibitor Therapy
TAMARA
A Non-Interventional Study Evaluating The Effects Of Aromatase Inhibitor Treatment After 2-3 Years Tamoxifen - As Adjuvant Endocrine Therapy - On Quality Of Life And Safety In Endocrine Responsive Early Stage Postmenopausal Breast Cancer Patients
1 other identifier
observational
344
1 country
16
Brief Summary
The purpose of this study is to follow safety and quality of life outcomes on patients switching from tamoxifen therapy to aromatase inhibitor therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2008
Typical duration for all trials
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 31, 2008
CompletedFirst Posted
Study publicly available on registry
November 4, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedMarch 15, 2012
March 1, 2012
3.5 years
October 31, 2008
March 14, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the quality of life of patients with early stage postmenopausal breast cancer using aromatase inhibitor following 2-3 years of tamoxifen treatment (switch)
2 years
Secondary Outcomes (1)
To evaluate patients with early stage postmenopausal breast cancer using aromatase inhibitor following 2-3 years of tamoxifen treatment (switch) in terms of side effects
2 years
Study Arms (1)
Aromatase inhibitors
Early stage postmenopausal breast cancer patients under tamoxifen treatment who are switching to aromatase inhibitor treatment
Interventions
Eligibility Criteria
Patients with endocrine responsive early stage postmenopausal breast cancer. Patients who received tamoxifen for 2-3 years as adjuvant endocrine therapy. Patients who were approved to switch to aromatase inhibitor treatment during the patient recruitment period. Patients who were informed about the study and accepted to participate.
You may qualify if:
- Patients with endocrine responsive early stage postmenopausal breast cancer. Patients who received tamoxifen for 2-3 years as adjuvant endocrine therapy. Patients who were approved to switch to aromatase inhibitor treatment during the patient recruitment period.
- Patients who were informed about the study and accepted to participate.
You may not qualify if:
- Patients having a psychological disorder which will prevent their understanding of questionnaires used for evaluation of quality of life and / or patients who are illiterate.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (16)
Pfizer Investigational Site
Adana, 01330, Turkey (Türkiye)
Pfizer Investigational Site
Ankara, 06100, Turkey (Türkiye)
Pfizer Investigational Site
Ankara, 06590, Turkey (Türkiye)
Pfizer Investigational Site
Ankara, Turkey (Türkiye)
Pfizer Investigational Site
Bursa, Turkey (Türkiye)
Pfizer Investigational Site
Denizli, Turkey (Türkiye)
Pfizer Investigational Site
Edirne, Turkey (Türkiye)
Pfizer Investigational Site
Erzurum, Turkey (Türkiye)
Pfizer Investigational Site
Gaziantep, Turkey (Türkiye)
Pfizer Investigational Site
Istanbul, 34303, Turkey (Türkiye)
Pfizer Investigational Site
Istanbul, Turkey (Türkiye)
Pfizer Investigational Site
Izmir, 35340, Turkey (Türkiye)
Pfizer Investigational Site
Izmir, Turkey (Türkiye)
Pfizer Investigational Site
Kocaeli, Turkey (Türkiye)
Pfizer Investigational Site
Malatya, Turkey (Türkiye)
Pfizer Investigational Site
Trabzon, Turkey (Türkiye)
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 31, 2008
First Posted
November 4, 2008
Study Start
June 1, 2008
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
March 15, 2012
Record last verified: 2012-03