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

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ClinicalTrials.gov Identifier: NCT01305239
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : February 28, 2011
Results First Posted : April 10, 2012
Last Update Posted : April 10, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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).

Condition or disease Intervention/treatment
Breast Cancer Drug: Aromasin

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 Design

Study Type : Observational
Actual Enrollment : 398 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Survey Of Clinical Practice Of Adjuvant Treatment Of Breast Cancer Using Exemestane (Aromasin®) In Postmenopausal Hr+ Patients
Study Start Date : October 2008
Primary Completion Date : May 2011
Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Exemestane
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Postmenopausal ER+ patients treated by Aromasin. Drug: Aromasin
Aromasin 25 mg daily.
Other Name: Exemestane


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
  2. 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.

  3. 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.

  4. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01305239


Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01305239     History of Changes
Other Study ID Numbers: NRA5990024
A5991095, ETAPE
First Posted: February 28, 2011    Key Record Dates
Results First Posted: April 10, 2012
Last Update Posted: April 10, 2012
Last Verified: November 2011

Keywords provided by Pfizer:
Observational
epidemiological
cohort
cross-sectional
prospective
multicenter
survey
France.

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Exemestane
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs