A Non-Interventional Study With Aromasin® As Adjuvant Treatment In Postmenopausal Women With Invasive, Estrogen Receptor Positive Early Breast Cancer Who Are Disease-Free After 2-3 Years Of Initial Adjuvant Tamoxifen Therapy

Aromasin® As Adjuvant Treatment In Postmenopausal Women With Invasive, Estrogen Receptor Positive Early Breast Cancer

Sponsors

Lead sponsor: Pfizer

Source Pfizer
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 postmenopausal women with invasive estrogen receptor positive early breast cancer , who are disease-free after completion of 2 to 3 years of tamoxifen and continue the treatment with Aromasin® until completion of 5 years of adjuvant hormonal therapy, to understand how Aromasin® is used in routine clinical practice, to assess adherence to prescribed Aromasin® treatment and to understand reasons for its early discontinuation.

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.

Overall Status Terminated
Start Date April 2011
Completion Date October 2011
Primary Completion Date October 2011
Study Type Observational
Primary Outcome
Measure Time Frame
Number of Participants With Adverse Events (AEs) Baseline up to Month 36
Secondary Outcome
Measure Time Frame
Number of Participants With Concomitant Morbidities Baseline up to Month 36
Number of Participants With Concomitant Medications Baseline up to Month 36
Percentage of Participants Who Discontinued the Study Medication Baseline up to Month 36
Number of Participants With Reasons for Discontinuation From Study Medication Baseline up to Month 36
Time to Discontinuation Baseline up to Month 36
Recurrence-free Survival Baseline up to Month 36
Overall Survival Baseline until death (up to Month 36)
Enrollment 46
Condition
Intervention

Intervention type: Drug

Intervention name: Aromasin

Description: Aromasin® one 25 mg tablet to be taken once daily

Arm group label: 1

Other name: Exemestane

Eligibility

Sampling method: Non-Probability Sample

Criteria:

Inclusion Criteria:

- Postmenopausal females, defined as one from the next :

1. Natural menopause ≥1 year,

2. Surgical ovariectomy,

3. 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 Criteria:

- 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.

Gender: Female

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Pfizer CT.gov Call Center Study Director Pfizer
Location
facility
General Hospital Karlovac | Karlovac, 47000, Croatia
University Hospital Center Osijek | Osijek, 31000, Croatia
General Hospital Pula | Pula, 52000, Croatia
University Hospital Center Rijeka | Rijeka, 51000, Croatia
University Hospital Center Split | Split, 21000, Croatia
General Hospital Varazdin | Varazdin, 42000, Croatia
Clinic for Tumors | Zagreb, 10000, Croatia
University Hospital Center "Sestre milosrdnice" | Zagreb, 10000, Croatia
North Estonia Medical Centre Foundation | Tallinn, 13419, Estonia
Institute for Oncology and Radiology of Serbia | Belgrade, 11000, Serbia
Oncology Clinic, Medical center, Bezanijska Kosa | Beograd, 11080, Serbia
Location Countries

Croatia

Estonia

Serbia

Verification Date

October 2012

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Arm group label: 1

Study Design Info

Observational model: Case Control

Time perspective: Prospective

Source: ClinicalTrials.gov