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Research Of Quality Of Life And Safety Outcomes Of Postmenopausal Breast Cancer Patients Switching From Tamoxifen Therapy To Aromatase Inhibitor Therapy (TAMARA)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00784888
First received: October 31, 2008
Last updated: March 14, 2012
Last verified: March 2012
History of Changes
  Purpose

The purpose of this study is to follow safety and quality of life outcomes on patients switching from tamoxifen therapy to aromatase inhibitor therapy.


Condition Intervention Phase
Breast Neoplasms
 Other: Aromatase inhibitors
 Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 344
Study Start Date: June 2008
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Aromatase inhibitors
Early stage postmenopausal breast cancer patients under tamoxifen treatment who are switching to aromatase inhibitor treatment
 Other: Aromatase inhibitors
non-interventional study

Detailed Description:

Group of patients using the same aromatase inhibitor

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

Inclusion 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.

Exclusion Criteria:

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00784888

Locations
Turkey
Pfizer Investigational Site
Adana, Turkey, 01330
Pfizer Investigational Site
Ankara, Turkey
Pfizer Investigational Site
Ankara, Turkey, 06100
Pfizer Investigational Site
Ankara, Turkey, 06590
Pfizer Investigational Site
Bursa, Turkey
Pfizer Investigational Site
Denizli, Turkey
Pfizer Investigational Site
Edirne, Turkey
Pfizer Investigational Site
Erzurum, Turkey
Pfizer Investigational Site
Gaziantep, Turkey
Pfizer Investigational Site
Istanbul, Turkey, 34303
Pfizer Investigational Site
Istanbul, Turkey
Pfizer Investigational Site
Izmir, Turkey
Pfizer Investigational Site
Izmir, Turkey, 35340
Pfizer Investigational Site
Kocaeli, Turkey
Pfizer Investigational Site
Malatya, Turkey
Pfizer Investigational Site
Trabzon, Turkey
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00784888     History of Changes
Other Study ID Numbers: A5991087
Study First Received: October 31, 2008
Last Updated: March 14, 2012
Health Authority: Turkey: Ministry of Health, Directory of Pharmacies and Pharmaceuticals

Keywords provided by Pfizer:
aromatase inhibitor
quality of life
safety
postmenopausal breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Tamoxifen
Aromatase Inhibitors
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
 Pharmacologic Actions
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents
Estrogen Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013