Sequencing Of Endocrine Therapy In Post-Menopausal Women With Early Breast Cancer (FAST)
NCT01050634
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Adult Trials: 18+ Years
- Early Breast Cancer, post-menopausal, 2-3 yrs adjuvant tamoxifen therapy.
- Not applicable.
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| Descriptive Information | ||||
|---|---|---|---|---|
| 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 |
| |||
| PRS Account | Pfizer | |||
| Verification Date | June 2010 | |||