Status:
TERMINATED
Evaluating The Safety Of Exemestane Following 2-3 Years Of Adjuvant Tamoxifen Therapy In Postmenopausal Early Breast Cancer Patients
Lead Sponsor:
Pfizer
Conditions:
Early Breast Cancer
Eligibility:
FEMALE
18-60 years
Brief Summary
Evaluating the safety, tolerability and efficacy of Aromasin® when used in routine clinical practice, evaluating adherence to prescribed Aromasin® treatment and to understand reasons for early discont...
Detailed Description
This study was terminated on 01-Aug-2011 due to very low potential to enroll planned number of patients or any sufficient number of patients for complete statistical analyses. This study is not being ...
Eligibility Criteria
Inclusion
- Postmenopausal females.
- Patients who have had surgical treatment for histological confirmed breast cancer that was non-metastatic at the time of the initial diagnosis.
- Patients who are disease-free after 2 or 3 years of adjuvant tamoxifen treatment.
- Patients whose tumour was estrogen receptor positive (ER+).
- Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
Exclusion
- Patients for whom Aromasin® treatment is contraindicated (see SPC).
- Presence of metastasis or a contra lateral tumour.
- Other adjuvant endocrine therapy.
- Another concomitant antineoplastic treatment.
- Participation in a clinical trial with an investigational drug during the 30 days prior to enrolment in the study.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
89 Patients enrolled
Trial Details
Trial ID
NCT01155063
Start Date
September 1 2010
End Date
September 1 2011
Last Update
October 1 2012
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