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

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

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.

Study Overview

• Status: Terminated
• Conditions: Breast Neoplasms
• Intervention / Treatment: Drug: Aromasin

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 Type: Observational
• Enrollment (Actual): 46

Contacts and Locations

Study Locations

• Croatia
  • Karlovac, Croatia, 47000
    • General Hospital Karlovac
  • Osijek, Croatia, 31000
    • University Hospital Center Osijek
  • Pula, Croatia, 52000
    • General Hospital Pula
  • Rijeka, Croatia, 51000
    • University Hospital Center Rijeka
  • Split, Croatia, 21000
    • University Hospital Center Split
  • Varazdin, Croatia, 42000
    • General Hospital Varazdin
  • Zagreb, Croatia, 10000
    • Clinic for Tumors
  • Zagreb, Croatia, 10000
    • University Hospital Center "Sestre milosrdnice"
• Estonia
  • Tallinn, Estonia, 13419
    • North Estonia Medical Centre Foundation
• Serbia
  • Belgrade, Serbia, 11000
    • Institute for Oncology and Radiology of Serbia
  • Beograd, Serbia, 11080
    • Oncology Clinic, Medical center, Bezanijska Kosa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Estrogen receptor positive early breast cancer patients

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1	Drug: Aromasin; Aromasin® one 25 mg tablet to be taken once daily; Other Names: Exemestane

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events (AEs)	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.	Baseline up to Month 36

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Concomitant Morbidities	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.	Baseline up to Month 36
Number of Participants With Concomitant Medications	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.	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	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.	Baseline up to Month 36
Overall Survival	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).	Baseline until death (up to Month 36)

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: November 3, 2010
• First Submitted That Met QC Criteria: November 10, 2010
• First Posted (Estimate): November 11, 2010

Study Record Updates

• Last Update Posted (Estimate): October 31, 2012
• Last Update Submitted That Met QC Criteria: October 11, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: Hormone adjuvant treatment of early breast cancer with aromatase inhibitors following 2-3 years of tamoxifen
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Aromatase Inhibitors; Steroid Synthesis Inhibitors; Estrogen Antagonists; Exemestane
• Other Study ID Numbers: A5991094