Clinical trial NCT01305239: A Survey Of Clinical Practice Of Adjuvant Treatment Of Breast Cancer Using Exemestane (Aromasin®) In Postmenopausal Hr+ Patients
Official title: A Survey Of Clinical Practice Of Adjuvant Treatment Of Breast Cancer Using Exemestane (Aromasin®) In Postmenopausal Hr+ Patients
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Breast Cancer
Keywords: Observational
epidemiological
cohort
cross-sectional
prospective
multicenter
survey
France.
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-02-28
Enrollment: 398
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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.

Primary outcomes:
measure: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed
Secondary outcomes:
measure: Reasons for Discontinuation of Aromasin Therapy
timeFrame: Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed
measure: Percentage of Participants Who Were Compliant With Treatment
timeFrame: Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed
measure: Duration of Treatment
timeFrame: Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed
measure: Event-free Survival
timeFrame: Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: