Evaluating The Safety Of Exemestane Following 2-3 Years Of Adjuvant Tamoxifen Therapy In Postmenopausal Early Breast Cancer Patients
|ClinicalTrials.gov Identifier: NCT01155063|
Recruitment Status : Terminated (See Detailed Description)
First Posted : July 1, 2010
Results First Posted : September 20, 2012
Last Update Posted : October 1, 2012
|Condition or disease||Intervention/treatment|
|Early Breast Cancer||Other: Aromasin (exemestane)|
|Study Type :||Observational|
|Actual Enrollment :||89 participants|
|Observational Model:||Case Control|
|Official Title:||A Non-Interventional Observational Study Evaluating The Effects Of Exemestane Following 2-3 Years Of Adjuvant Tamoxifen Therapy On Safety In Postmenopausal And Hormone Receptors Positive Early Breast Cancer Patients|
|Study Start Date :||September 2010|
|Primary Completion Date :||September 2011|
|Study Completion Date :||September 2011|
Postmenopausal Women With Invasive, Estrogen Receptor Positive Early Breast Cancer Who Are Disease-Free After 2-3 Years Of Initial Adjuvant Tamoxifen Therapy
Other: Aromasin (exemestane)
Aromasin (exemestane), tablets 25 mg, once a day
Other Name: Aromasin, exemestane
- Number of Participants With Adverse Events (AEs) [ Time Frame: Month 0 up to Month 36 or early withdrawal ]An AE was any untoward medical occurrence attributed to study medication in a participant who received study medication.
- Number of Participants With Concomitant Morbidities [ Time Frame: Month 0 up to Month 36 or early withdrawal ]Participants who had a concomitant morbidity during the study for any period of time; participants with more than one concomitant morbidity were counted for each of the concomitant morbidity classes applicable.
- Number of Participants With Concomitant Medications [ Time Frame: Month 0 up to Month 36 or early withdrawal ]Concomitant medication (any medication other than, and in addition to, the study medication) taken for any period of time during the study and was coded by World Health Organization (WHO) medical dictionary.
- Percentage of Participants Who Discontinued the Study Medication [ Time Frame: Month 0 up to Month 36 or early withdrawal ]
- Number of Participants With Reasons for Discontinuation From Study Treatment [ Time Frame: Month 0 up to Month 36 or early withdrawal ]
- Time to Discontinuation of Study Medication [ Time Frame: Month 0 up to Month 36 or early withdrawal ]
- Percentage of Participants With Recurrent Disease [ Time Frame: Month 36 or early withdrawal ]Percentage of participants with confirmed recurrent disease at the end of the study (recurrence was defined as loco-regional and/or contralateral and/or distance metastases).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01155063
|Study Director:||Pfizer CT.gov Call Center||Pfizer|