A Survey Of Clinical Practice Of Adjuvant Treatment Of Breast Cancer Using Exemestane (Aromasin®) In Postmenopausal Hr+ Patients (ETAPE)

March 8, 2012 updated by: Pfizer
Observational survey aiming to evaluate the tolerability of Aromasin and the ways in which it is used in clinical practice in France (as adjuvant endocrine therapy).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

It was hypothesized that 200 participating doctors would provide the survey with sufficient statistical precision to meet the objectives, with each participating doctor recruiting up to 6 patients. An initial sample of 1000 doctors should be contacted (letter, phone).

These 1000 doctors will initially be chosen at random from a file held by Pfizer of doctors who have agreed to take part in a Pfizer survey.

These doctors will be experienced and qualified in the treatment and management of patients with non-metastatic, surgically-treated breast cancer (medical oncologists, gynaecologists, and medical oncologists/ radiation oncologists). They are practicing in general hospitals, teaching hospitals, CRLCC cancer centres and private clinics treating patients with breast cancer.

Study recruitment was stopped due to difficulty in enrolling the targeted number of patients on December 3, 2010. There were no safety concerns involved in the decision to stop enrollment.

Study Type

Observational

Enrollment (Actual)

398

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Postmenopausal patients, hormone receptor positive, who have had surgical treatment for histologically confirmed early breast cancer that was nonmetastatic at the time of the initial diagnosis, treated by Aromasin as adjuvant endocrine therapy.

Description

Inclusion Criteria:

Postmenopausal patients, defined as: natural menopause for at least 1 year, surgical ovariectomy, chemotherapy-induced amenorrhoea for at least 2 years.

Patients who have had surgical treatment for histologically confirmed breast cancer that was nonmetastatic at the time of the initial diagnosis.

Patients whose tumour was hormone receptor positive (HR+, ER+ and/or PR+). Patients initiated on Aromasin at least 2 months before inclusion but not more than 1 year.

Exclusion Criteria:

Patients for whom Aromasin treatment is contraindicated. Presence of metastasis or a contralateral tumour. Another adjuvant endocrine therapy. Another concomitant antineoplastic treatment (except for Herceptin®). Participation in a clinical trial with an investigational drug during the 30 days prior to enrolment in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Postmenopausal ER+ patients treated by Aromasin.
Drug: Aromasin
Aromasin 25 mg daily.
Other Names:
  • Exemestane

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed
Any untoward medical occurrence in a patient who received study drug was considered an adverse event without regard to possibility of causal relationship. An adverse event resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a serious adverse event: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reasons for Discontinuation of Aromasin Therapy
Time Frame: Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed
Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed
Percentage of Participants Who Were Compliant With Treatment
Time Frame: Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed
Compliant with treatment = followed treatment regimen with exemestane according to initial prescription.
Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed
Duration of Treatment
Time Frame: Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed
Total duration of adjuvant hormonal therapy with exemestane.
Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed
Event-free Survival
Time Frame: Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed
Event-free survival: time between first intake of exemestane and date of last follow-up or date of death for deceased participants (date of relapse or death or last follow-up minus first intake date) + 1 / 365.25 * 12.
Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

February 24, 2011

First Submitted That Met QC Criteria

February 24, 2011

First Posted (Estimate)

February 28, 2011

Study Record Updates

Last Update Posted (Estimate)

April 10, 2012

Last Update Submitted That Met QC Criteria

March 8, 2012

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NRA5990024
  • A5991095, ETAPE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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