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

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01239745
• Other study ID #: A5991094
• Status: Terminated
• Phase: Phase 4
• First received: November 3, 2010
• Last updated: October 11, 2012
• Start date: April 2011
• Est. completion date: October 2011

Study information

• Verified date: October 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Croatia: Ministry of Health and Social Care
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 46
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
Croatia	General Hospital Karlovac	Karlovac
Croatia	University Hospital Center Osijek	Osijek
Croatia	General Hospital Pula	Pula
Croatia	University Hospital Center Rijeka	Rijeka
Croatia	University Hospital Center Split	Split
Croatia	General Hospital Varazdin	Varazdin
Croatia	Clinic for Tumors	Zagreb
Croatia	University Hospital Center "Sestre milosrdnice"	Zagreb
Estonia	North Estonia Medical Centre Foundation	Tallinn
Serbia	Institute for Oncology and Radiology of Serbia	Belgrade
Serbia	Oncology Clinic, Medical center, Bezanijska Kosa	Beograd

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Croatia,  Estonia,  Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No
Secondary	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	No
Secondary	Percentage of Participants Who Discontinued the Study Medication		Baseline up to Month 36	No
Secondary	Number of Participants With Reasons for Discontinuation From Study Medication		Baseline up to Month 36	No
Secondary	Time to Discontinuation		Baseline up to Month 36	No
Secondary	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	No
Secondary	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)	No

External Links

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