Sequencing Of Endocrine Therapy In Post-Menopausal Women With Early Breast Cancer (FAST)
NCT01050634
ABOUT THIS STUDY
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- Early Breast Cancer, post-menopausal, 2-3 yrs adjuvant tamoxifen therapy.
- Not applicable.
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Descriptive Information | ||||
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Brief Title | Sequencing Of Endocrine Therapy In Post-Menopausal Women With Early Breast Cancer (FAST) | |||
Official Title | Sequencing Of Endocrine Therapy In Post-Menopausal Women With Early Breast Cancer (FAST) a Non-interventional Trial With Aromasin® | |||
Brief Summary | Quality of life under therapy with Aromasin® (exemestane) according to IBCSG (International Breast Cancer Study Group) questionnaire. Change of the endometrium after switching from tamoxifen to Aromasin® (exemestane). Deeper knowledge of Adverse Events during routine administration. | |||
Detailed Description | Not Provided | |||
Study Type | Observational | |||
Study Design | Observational Model: Case-Only Time Perspective: Prospective | |||
Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Non-Probability Sample | |||
Study Population | Early Breast Cancer, post-menopausal, 2-3 yrs adjuvant tamoxifen therapy | |||
Condition | Post Menopausal Women With Early Breast Cancer | |||
Intervention | Drug: Aromasin (exemestane)
25mg oral tablet, daily, for >1yr Other Name: Aromasin, exemestane | |||
Study Groups/Cohorts | Observational
Intervention: Drug: Aromasin (exemestane) | |||
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 | 980 | |||
Original Actual Enrollment | 984 | |||
Actual Study Completion Date | April 2009 | |||
Actual Primary Completion Date | April 2009 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | Child, Adult, Older Adult | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT01050634 | |||
Other Study ID Numbers | A5991079 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
Study Sponsor | Pfizer | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | Pfizer | |||
Verification Date | June 2010 |