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

• Sponsor: Pfizer (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01305239
• Collaborator: (none)
• Enrollment: 398
• Duration (Months): 30.9

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: Aromasin

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 398 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Survey Of Clinical Practice Of Adjuvant Treatment Of Breast Cancer Using Exemestane (Aromasin®) In Postmenopausal Hr+ Patients
• Study Start Date: Oct 1, 2008
• Actual Primary Completion Date: May 1, 2011
• Actual Study Completion Date: May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Postmenopausal ER+ patients treated by Aromasin.	Drug: Aromasin; Aromasin 25 mg daily.; Other Names: Exemestane

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Reasons for Discontinuation of Aromasin Therapy [Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed]

2. 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.

3. 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.

4. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01305239
• Other Study ID Numbers: NRA5990024; A5991095, ETAPE
• First Posted: Feb 28, 2011
• Last Update Posted: Apr 10, 2012
• Last Verified: Nov 1, 2011

• Keywords provided by Pfizer: Observational; epidemiological; cohort; cross-sectional; prospective; multicenter; survey; France.
• Additional relevant MeSH terms: Breast Neoplasms; Exemestane

Study Results

Participant Flow

Arm/Group Title	Exemestane
Arm/Group Description	25 mg oral tablet once a day
Period Title: Overall Study
STARTED	398
Safety Set	397
Intent to Treat Population	287
COMPLETED	375
NOT COMPLETED	23

Baseline Characteristics

Arm/Group Title	Exemestane
Arm/Group Description	25 mg oral tablet once a day
Overall Participants	397
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63.1 (10.3)
Sex: Female, Male (Count of Participants)
Female	397 100%
Male	0 0%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
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.
Time Frame	Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed

Outcome Measure Data

Analysis Population Description

Safety set: all participants who received at least 1 dose of study medication.

Arm/Group Title	Exemestane
Arm/Group Description	25 mg oral tablet once a day
Measure Participants	397
AE	41.6 10.5%
SAE	0.5 0.1%

2. Secondary Outcome

Title	Reasons for Discontinuation of Aromasin Therapy
Time Frame	Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed

Outcome Measure Data

Analysis Population Description

Safety set. N = number of participants with follow-up visit(s) who discontinued treatment with exemestane.

Arm/Group Title	Exemestane
Arm/Group Description	25 mg oral tablet once a day
Measure Participants	45
Therapeutic choice	9 2.3%
Adverse events	36 9.1%

3. Secondary Outcome

Title	Percentage of Participants Who Were Compliant With Treatment
Description	Compliant with treatment = followed treatment regimen with exemestane according to initial prescription.
Time Frame	Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed

Outcome Measure Data

Analysis Population Description

Safety set. Information on compliance was not available for subjects who did not have a follow-up visit. N = number of participants with analyzable data.

Arm/Group Title	Exemestane
Arm/Group Description	25 mg oral tablet once a day
Measure Participants	286
Number (95% Confidence Interval) [percentage of participants]	90.2 22.7%

4. Secondary Outcome

Title	Duration of Treatment
Description	Total duration of adjuvant hormonal therapy with exemestane.
Time Frame	Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed

Outcome Measure Data

Analysis Population Description

Safety set; N = number of participants with analyzable (non-missing) data. For 2 participants lost to follow-up, the duration of exemestane was calculated until the date of lost to follow-up.

Arm/Group Title	Exemestane
Arm/Group Description	25 mg oral tablet once a day
Measure Participants	252
Mean (Standard Deviation) [months]	15.9 (7.8)

5. Secondary Outcome

Title	Event-free Survival
Description	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.
Time Frame	Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed

Outcome Measure Data

Analysis Population Description

ITT population = all participants who received at least 1 dose of study drug and had at least 1 follow-up questionnaire completed. N = number of participants with analyzable (non-missing) data.

Arm/Group Title	Exemestane
Arm/Group Description	25 mg oral tablet once a day
Measure Participants	251
Mean (95% Confidence Interval) [months]	16.2

Adverse Events

Adverse Event Reporting Description	The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Arm/Group Title	Exemestane
Arm/Group Description	25 mg oral tablet once a day
All Cause Mortality
	Exemestane
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Exemestane
	Affected / at Risk (%)	# Events
Total	2/397 (0.5%)
Cardiac disorders
Cardiac failure	1/397 (0.3%)
Musculoskeletal and connective tissue disorders
Osteoporosis	1/397 (0.3%)
Respiratory, thoracic and mediastinal disorders
Pleural effusion	1/397 (0.3%)
Other (Not Including Serious) Adverse Events
	Exemestane
	Affected / at Risk (%)	# Events
Total	173/397 (43.6%)
Cardiac disorders
Arrhythmia	1/397 (0.3%)
Ear and labyrinth disorders
Deafness	1/397 (0.3%)
Vertigo	1/397 (0.3%)
Gastrointestinal disorders
Constipation	1/397 (0.3%)
Diarrhoea	1/397 (0.3%)
Dry mouth	1/397 (0.3%)
Dyspepsia	1/397 (0.3%)
Gastrooesophageal reflux disease	1/397 (0.3%)
Nausea	2/397 (0.5%)
Oral discomfort	1/397 (0.3%)
General disorders
Adverse drug reaction	2/397 (0.5%)
Chest discomfort	1/397 (0.3%)
Fatigue	51/397 (12.8%)
Malaise	1/397 (0.3%)
Oedema peripheral	1/397 (0.3%)
Pain	2/397 (0.5%)
Sense of oppression	1/397 (0.3%)
Missing code	8/397 (2%)
Infections and infestations
Cystitis escherichia	1/397 (0.3%)
Injury, poisoning and procedural complications
Ankle fracture	1/397 (0.3%)
Epicondylitis	1/397 (0.3%)
Fall	2/397 (0.5%)
Femoral neck fracture	2/397 (0.5%)
Fracture	3/397 (0.8%)
Scapula fracture	1/397 (0.3%)
Upper limb fracture	1/397 (0.3%)
Wrist fracture	2/397 (0.5%)
Investigations
Quality of life decreased	2/397 (0.5%)
Weight increased	2/397 (0.5%)
Metabolism and nutrition disorders
Dyslipidaemia	1/397 (0.3%)
Hypercalcaemia	1/397 (0.3%)
Hypercholesterolaemia	16/397 (4%)
Hypertriglyceridaemia	4/397 (1%)
Hyponatraemia	1/397 (0.3%)
Metabolic disorder	3/397 (0.8%)
Musculoskeletal and connective tissue disorders
Arthralgia	89/397 (22.4%)
Back pain	2/397 (0.5%)
Fibromyalgia	1/397 (0.3%)
Joint stiffness	3/397 (0.8%)
Muscle spasms	2/397 (0.5%)
Musculoskeletal chest pain	1/397 (0.3%)
Musculoskeletal pain	17/397 (4.3%)
Musculoskeletal stiffness	3/397 (0.8%)
Myalgia	2/397 (0.5%)
Osteoarthritis	3/397 (0.8%)
Osteopenia	34/397 (8.6%)
Osteoporosis	12/397 (3%)
Pain in extremity	1/397 (0.3%)
Periarthritis	1/397 (0.3%)
Rotator cuff syndrome	1/397 (0.3%)
Tendonitis	1/397 (0.3%)
Tenosynovitis	1/397 (0.3%)
Trigger finger	1/397 (0.3%)
Nervous system disorders
Headache	11/397 (2.8%)
Paraesthesia	1/397 (0.3%)
Sciatica	1/397 (0.3%)
Tension headache	1/397 (0.3%)
Psychiatric disorders
Affective disorder	1/397 (0.3%)
Anxiety	2/397 (0.5%)
Depressed mood	1/397 (0.3%)
Depression	17/397 (4.3%)
Insomnia	1/397 (0.3%)
Libido decreased	4/397 (1%)
Libido disorder	14/397 (3.5%)
Sexual inhibition	1/397 (0.3%)
Sleep disorder	1/397 (0.3%)
Renal and urinary disorders
Renal failure	1/397 (0.3%)
Reproductive system and breast disorders
Breast discomfort	1/397 (0.3%)
Breast pain	1/397 (0.3%)
Endometrial hypertrophy	1/397 (0.3%)
Genital disorder female	4/397 (1%)
Menometrorrhagia	1/397 (0.3%)
Metrorrhagia	3/397 (0.8%)
Vaginal discharge	1/397 (0.3%)
Vaginal haemorrhage	4/397 (1%)
Skin and subcutaneous tissue disorders
Alopecia	2/397 (0.5%)
Hyperhidrosis	1/397 (0.3%)
Rash	2/397 (0.5%)
Surgical and medical procedures
Dialysis	1/397 (0.3%)
Vascular disorders
Axillary vein thrombosis	1/397 (0.3%)
Hot flush	59/397 (14.9%)
Hypertension	7/397 (1.8%)
Phlebitis	1/397 (0.3%)

Limitations/Caveats

Study recruitment was stopped due to difficulty enrolling the target number of participants. There were no safety concerns in the decision to terminate this study.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.