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

Terminated

• Conditions: Breast Cancer
• Interventions: Drug: Aromasin

• Registration Number: NCT01305239
• Lead Sponsor: Pfizer

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).

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 Timeline

• Study Start: 2008-10
• Study First Submitted: 2011-02-24
• Study First Submitted QC: 2011-02-24
• Study First Posted: 2011-02-28
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2011-11
• Results First Submitted: 2012-03-08
• Results First Submitted QC: 2012-03-08
• Last Update Submitted: 2012-03-08
• Results First Posted: 2012-04-10
• Last Update Posted: 2012-04-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 398

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Postmenopausal ER+ patients treated by Aromasin.	Aromasin	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	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

Name	Time	Method
Reasons for Discontinuation of Aromasin Therapy	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	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.
Duration of Treatment	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.
Event-free Survival	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.