Evaluating The Safety Of Exemestane Following 2-3 Years Of Adjuvant Tamoxifen Therapy In Postmenopausal Early Breast Cancer Patients
NCT01155063
ABOUT THIS STUDY
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- 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.
- 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.
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Descriptive Information | ||||
---|---|---|---|---|
Brief Title | Evaluating The Safety Of Exemestane Following 2-3 Years Of Adjuvant Tamoxifen Therapy In Postmenopausal Early Breast Cancer Patients | |||
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 | |||
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 discontinuation. | |||
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 terminated because of safety or efficacy concerns. | |||
Study Type | Observational | |||
Study Design | Observational Model: Case-Control Time Perspective: Prospective | |||
Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Non-Probability Sample | |||
Study Population | Postmenopausal Women With Invasive, Estrogen Receptor Positive Early Breast Cancer Who Are Disease-Free After 2-3 Years Of Initial Adjuvant Tamoxifen Therapy | |||
Condition | Early Breast Cancer | |||
Intervention | Other: Aromasin (exemestane)
Aromasin (exemestane), tablets 25 mg, once a day Other Name: Aromasin, exemestane | |||
Study Groups/Cohorts | Main Group
Postmenopausal Women With Invasive, Estrogen Receptor Positive Early Breast Cancer Who Are Disease-Free After 2-3 Years Of Initial Adjuvant Tamoxifen Therapy Intervention: Other: 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 | Terminated | |||
Actual Enrollment | 89 | |||
Original Estimated Enrollment | 600 | |||
Actual Study Completion Date | September 2011 | |||
Actual Primary Completion Date | September 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender |
| |||
Ages | 18 Years to 60 Years (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 | NCT01155063 | |||
Other Study ID Numbers | A5991092 | |||
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 | September 2012 |