Research Of Quality Of Life And Safety Outcomes Of Postmenopausal Breast Cancer Patients Switching From Tamoxifen Therapy To Aromatase Inhibitor Therapy
NCT00784888
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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.
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.
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| 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 | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status | Completed | |||
| Actual Enrollment | 344 | |||
| Original Estimated Enrollment | 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 |
| |||
| 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 | |||
| Removed Location Countries | ||||
| 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 |
| |||
| PRS Account | Pfizer | |||
| Verification Date | March 2012 | |||