Status:
TERMINATED
Aromasin® As Adjuvant Treatment In Postmenopausal Women With Invasive, Estrogen Receptor Positive Early Breast Cancer
Lead Sponsor:
Pfizer
Conditions:
Breast Neoplasms
Eligibility:
FEMALE
Brief Summary
This non-interventional study will be conducted in several Eastern European countries to assess the safety, tolerability and efficacy of Aromasin® when it is administered in real-word setting in postm...
Detailed Description
The study prematurely discontinued on October 11, 2011 due to slow enrollment. It should be noted that safety concerns have not been seen in this study and have not factored into this decision.
Eligibility Criteria
Inclusion
- Postmenopausal females, defined as one from the next :
- Natural menopause ≥1 year,
- Surgical ovariectomy,
- Chemotherapy-induced amenorrhoea ≥ 2 years.
- Patients who have had surgical treatment for histologically confirmed breast cancer that was non-metastatic at the time of the initial diagnosis.
- Patients who are disease-free after 2 to 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 SmPC).
- Metastatic breast cancer or a contra lateral tumour.
- Other concomitant adjuvant endocrine therapy.
- Other 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 :
April 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT01239745
Start Date
April 1 2011
End Date
October 1 2011
Last Update
October 31 2012
Active Locations (11)
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1
General Hospital Karlovac
Karlovac, Croatia, 47000
2
University Hospital Center Osijek
Osijek, Croatia, 31000
3
General Hospital Pula
Pula, Croatia, 52000
4
University Hospital Center Rijeka
Rijeka, Croatia, 51000