Clinical Trials Logo
  1. Home
  2. Breast Neoplasms
  3. NCT00784888
  4. Details
NCT00784888 Clinical Trial

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

Breast Neoplasms Clinical Trial

— TAMARA  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00784888
Other study ID # A5991087
Secondary ID
Status Completed
Phase Phase 4
First received October 31, 2008
Last updated March 14, 2012
Start date June 2008
Est. completion date December 2011

Study information
Verified date March 2012
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority Turkey: Ministry of Health, Directory of Pharmacies and Pharmaceuticals
Study type Observational

Clinical Trial 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.

Description:

Group of patients using the same aromatase inhibitor

Recruitment information / eligibility
Status Completed
Enrollment 344
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Female
Age group 40 Years and older
Eligibility 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• Aromatase inhibitors
non-interventional study

Locations
Country Name City State
Turkey Pfizer Investigational Site Adana
Turkey Pfizer Investigational Site Ankara
Turkey Pfizer Investigational Site Ankara
Turkey Pfizer Investigational Site Ankara
Turkey 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 Pfizer Investigational Site Istanbul
Turkey Pfizer Investigational Site Izmir
Turkey Pfizer Investigational Site Izmir
Turkey Pfizer Investigational Site Kocaeli
Turkey Pfizer Investigational Site Malatya
Turkey Pfizer Investigational Site Trabzon

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Yes
Secondary 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 Yes
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT05558917 - Comparison Between PECS BLOCK 2 vs ESP BLOCK in Ocnologic Breast Surgery N/A
Active, not recruiting NCT03664778 - Abbreviated Breast MRI After Cancer Treatment
Recruiting NCT03144622 - 18F-FSPG PET/CT Imaging in Patients With Cancers
Completed NCT05452499 - Pain Neuroscience Education and Therapeutic Exercise as a Treatment for Breast Cancer Survivors Living With Sequelae N/A
Active, not recruiting NCT04568902 - Study of H3B-6545 in Japanese Women With Estrogen Receptor (ER)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer Phase 1
Completed NCT02860585 - Evaluation of Survival in Patients With Metastatic Breast Cancer Receiving High-dose Chemotherapy With Autologous Haematopoietic Stem Cell Transplantation N/A
Completed NCT04059809 - Photobiomodulation for Breast Cancer Radiodermatitis Phase 2/Phase 3
Recruiting NCT04557449 - Study to Test the Safety and Tolerability of PF-07220060 in Participants With Advance Solid Tumors Phase 1/Phase 2
Completed NCT03698942 - Delphinus SoftVue™ ROC Reader Study
Completed NCT00092950 - Exercise in Women at Risk for Breast Cancer Phase 2
Terminated NCT04123704 - Sitravatinib in Metastatic Breast Cancer Phase 2
Not yet recruiting NCT02151071 - The Breast Surgery EnLight and LightPath Imaging System Study Phase 1/Phase 2
Recruiting NCT02934360 - TR(ACE) Assay Clinical Specimen Study N/A
Active, not recruiting NCT02950064 - A Study to Determine the Safety of BTP-114 for Treatment in Patients With Advanced Solid Tumors With BRCA Mutations Phase 1
Completed NCT02931552 - Nuevo Amanecer II: Translating a Stress Management Program for Latinas N/A
Not yet recruiting NCT02876848 - A Novel E-Health Approach in Optimizing Treatment for Seniors (OPTIMUM Study) N/A
Recruiting NCT02547545 - Breast Cancer Chemotherapy Risk Prediction Mathematical Model N/A
Completed NCT02518477 - Preventive Intervention Against Lymphedema After Breast Cancer Surgery N/A
Completed NCT02652975 - Anticancer Treatment of Breast Cancer Related to Cardiotoxicity and Dysfunctional Endothelium N/A
Completed NCT02303366 - Pilot Study of Stereotactic Ablation for Oligometastatic Breast Neoplasia in Combination With the Anti-PD-1 Antibody MK-3475 Phase 1

External Links