DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breast Cancer

Intervention: Aromasin (Drug)

Phase: N/A

Status: Terminated

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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).

Clinical Details

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

Study design: Observational Model: Cohort, Time Perspective: Prospective

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

Secondary outcome:

Reasons for Discontinuation of Aromasin Therapy

Percentage of Participants Who Were Compliant With Treatment

Duration of Treatment

Event-free Survival

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.

Eligibility

Minimum age: 45 Years. Maximum age: N/A. Gender(s): Female.

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.

Locations and Contacts

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: October 2008
Last updated: March 8, 2012

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017