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

• ClinicalTrials.gov Identifier: NCT00784888
• Recruitment Status: Completed
• First Posted: November 4, 2008
• Last Update Posted: March 15, 2012
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: October 31, 2008
• First Posted Date: November 4, 2008
• Last Update Posted Date: March 15, 2012
• Study Start Date: June 2008
• Actual Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: November 3, 2008): 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 ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: November 3, 2008): 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 ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Research Of Quality Of Life And Safety Outcomes Of Postmenopausal Breast Cancer Patients Switching From Tamoxifen Therapy To Aromatase Inhibitor Therapy
• 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
• 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.
• Detailed Description: Group of patients using the same aromatase inhibitor
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.

• Condition: Breast Neoplasms

Intervention

Other: Aromatase inhibitors

non-interventional study

Study Groups/Cohorts

Aromatase inhibitors

Early stage postmenopausal breast cancer patients under tamoxifen treatment who are switching to aromatase inhibitor treatment

Intervention: Other: Aromatase inhibitors

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 14, 2012): 344
• Original Estimated Enrollment (submitted: November 3, 2008): 1000
• Actual Study Completion Date: December 2011
• Actual Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 40 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Turkey

Administrative Information

• NCT Number: NCT00784888
• Other Study ID Numbers: A5991087
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Pfizer
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: March 2012