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

NCT ID: NCT01239745

Last Updated: 2012-10-31

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

46 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-04-30

Study Completion Date

2011-10-31

Brief Summary

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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

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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.

Conditions

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Breast Neoplasms

Keywords

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Hormone adjuvant treatment of early breast cancer with aromatase inhibitors following 2-3 years of tamoxifen

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Aromasin

Intervention Type DRUG

Aromasin® one 25 mg tablet to be taken once daily

Interventions

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Aromasin

Aromasin® one 25 mg tablet to be taken once daily

Intervention Type DRUG

Other Intervention Names

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Exemestane

Eligibility Criteria

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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.
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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General Hospital Karlovac

Karlovac, , Croatia

Site Status

University Hospital Center Osijek

Osijek, , Croatia

Site Status

General Hospital Pula

Pula, , Croatia

Site Status

University Hospital Center Rijeka

Rijeka, , Croatia

Site Status

University Hospital Center Split

Split, , Croatia

Site Status

General Hospital Varazdin

Varaždin, , Croatia

Site Status

Clinic for Tumors

Zagreb, , Croatia

Site Status

University Hospital Center "Sestre milosrdnice"

Zagreb, , Croatia

Site Status

North Estonia Medical Centre Foundation

Tallinn, , Estonia

Site Status

Institute for Oncology and Radiology of Serbia

Belgrade, , Serbia

Site Status

Oncology Clinic, Medical center, Bezanijska Kosa

Belgrade, , Serbia

Site Status

Countries

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Croatia Estonia Serbia

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5991094&StudyName=Aromasin%AE%20As%20Adjuvant%20Treatment%20In%20Postmenopausal%20Women%20With%20Invasive%2C%20Estrogen%20Receptor%20Positive%20Early%20Breast%20Cancer

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

Other Identifiers

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A5991094

Identifier Type: -

Identifier Source: org_study_id