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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01305239

Acronym

ETAPE

Enrollment

398

Registered

2011-02-28

Start date

2008-10-31

Completion date

2011-05-31

Last updated

2012-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Observational, epidemiological, cohort, cross-sectional, prospective, multicenter, survey, France.

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.

Interventions

DRUGAromasin

Aromasin 25 mg daily.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

45 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Participant flow

Participants by arm

Arm	Count
Exemestane 25 mg oral tablet once a day	397
Total	397

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	22
Overall Study	Exemestane taken prior to inclusion only	1

Baseline characteristics

Characteristic	Exemestane
Age Continuous	63.1 years STANDARD_DEVIATION 10.3
Sex: Female, Male Female	397 Participants
Sex: Female, Male Male	0 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	173 / 397
serious Total, serious adverse events	2 / 397

Outcome results

Primary

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

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.