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

45 Years
Not Enrolling
Breast Cancer

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Trial Information

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

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

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

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.

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed

Safety Issue:


Principal Investigator

Pfizer Call Center

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

October 2008

Completion Date:

May 2011

Related Keywords:

  • Breast Cancer
  • Observational
  • epidemiological
  • cohort
  • cross-sectional
  • prospective
  • multicenter
  • survey
  • France.
  • Breast Neoplasms