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

Terminated

• Conditions: Breast Neoplasms
• Interventions: Drug: Aromasin

• Registration Number: NCT01239745
• Lead Sponsor: 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.

Study Timeline

• Study First Submitted: 2010-11-03
• Study First Submitted QC: 2010-11-10
• Study First Posted: 2010-11-11
• Study Start: 2011-04
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2012-10
• Results First Submitted: 2012-10-11
• Results First Submitted QC: 2012-10-11
• Last Update Submitted: 2012-10-11
• Results First Posted: 2012-10-31
• Last Update Posted: 2012-10-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 46

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Aromasin	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events (AEs)	Baseline up to Month 36	Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness (to study drug) was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Concomitant Morbidities	Baseline up to Month 36	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	Baseline up to Month 36	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	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	Recurrence-free survival defined as the time from the initiation of study medication to the date of confirmation of any recurrence - as local or distant breast cancer recurrence; new primary breast cancer (ipsilateral or contralateral), death due to any cause.
Overall Survival	Baseline until death (up to Month 36)	Time in months from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).

Trial Locations

Locations (11)

University Hospital Center Osijek; 🇭🇷 Osijek, Croatia

University Hospital Center Split; 🇭🇷 Split, Croatia

North Estonia Medical Centre Foundation; 🇪🇪 Tallinn, Estonia

University Hospital Center Rijeka; 🇭🇷 Rijeka, Croatia

University Hospital Center "Sestre milosrdnice"; 🇭🇷 Zagreb, Croatia

Institute for Oncology and Radiology of Serbia; 🇷🇸 Belgrade, Serbia

Oncology Clinic, Medical center, Bezanijska Kosa; 🇷🇸 Beograd, Serbia

General Hospital Karlovac; 🇭🇷 Karlovac, Croatia

Clinic for Tumors; 🇭🇷 Zagreb, Croatia

General Hospital Pula; 🇭🇷 Pula, Croatia

General Hospital Varazdin; 🇭🇷 Varazdin, Croatia