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

Last updated on May 10, 2018

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Cancer
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
45+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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.

NCT01305239
Pfizer
Terminated
A Survey Of Clinical Practice Of Adjuvant Treatment Of Breast Cancer Using Exemestane (Aromasin®) In Postmenopausal Hr+ Patients

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

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
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.
Breast Cancer
Drug: Aromasin
Aromasin 25 mg daily.
Other Name: Exemestane
Postmenopausal ER+ patients treated by Aromasin.
Intervention: Drug: Aromasin
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
398
May 2011
May 2011   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: Female
45 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01305239
NRA5990024
A5991095, ETAPE
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2011

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