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| ID | Type | Description | Link |
|---|---|---|---|
| A5991095, ETAPE |
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See termination reason in detailed description.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Postmenopausal ER+ patients treated by Aromasin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aromasin | Drug | Aromasin 25 mg daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Compliant with treatment = followed treatment regimen with exemestane according to initial prescription. |
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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.
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Exemestane | 25 mg oral tablet once a day |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Exemestane | 25 mg oral tablet once a day |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | N = 392, number of participants with baseline age data. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Safety set: all participants who received at least 1 dose of study medication. | Posted | Number | percentage of participants | Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed |
|
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Exemestane | 25 mg oral tablet once a day |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arrhythmia | Cardiac disorders | MedDRA 13.0 | Non-systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C056516 | exemestane |
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| Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed |
| Duration of Treatment | Total duration of adjuvant hormonal therapy with exemestane. | Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed |
| Event-free Survival | 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. | Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Reasons for Discontinuation of Aromasin Therapy | Safety set. N = number of participants with follow-up visit(s) who discontinued treatment with exemestane. | Posted | Number | participants | Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed |
|
|
|
| Secondary | Percentage of Participants Who Were Compliant With Treatment | Compliant with treatment = followed treatment regimen with exemestane according to initial prescription. | 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. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed |
|
|
|
| Secondary | Duration of Treatment | Total duration of adjuvant hormonal therapy with exemestane. | 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. | Posted | Mean | Standard Deviation | months | Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed |
|
|
|
| Secondary | Event-free Survival | 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. | 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. | Posted | Mean | 95% Confidence Interval | months | Baseline, every 6 months until adjuvant hormonal therapy stopped or up to 5 years of therapy completed |
|
|
|
| 2 |
| 397 |
| 173 |
| 397 |
| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Deafness | Ear and labyrinth disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Oral discomfort | Gastrointestinal disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Adverse drug reaction | General disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Pain | General disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Sense of oppression | General disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Cystitis escherichia | Infections and infestations | MedDRA 13.0 | Non-systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
|
| Epicondylitis | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
|
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
|
| Fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
|
| Scapula fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
|
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Non-systematic Assessment |
|
| Quality of life decreased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
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| Weight increased | Investigations | MedDRA 13.0 | Non-systematic Assessment |
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| Dyslipidaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Metabolic disorder | Metabolism and nutrition disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Missing code | General disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Fibromyalgia | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Osteopenia | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Osteoporosis | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Trigger finger | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Tension headache | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Affective disorder | Psychiatric disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Depressed mood | Psychiatric disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Libido decreased | Psychiatric disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Libido disorder | Psychiatric disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Sexual inhibition | Psychiatric disorders | MedDRA 13.0 | Non-systematic Assessment |
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| Sleep disorder | Psychiatric disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Renal failure | Renal and urinary disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Breast discomfort | Reproductive system and breast disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Breast pain | Reproductive system and breast disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Endometrial hypertrophy | Reproductive system and breast disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Genital disorder female | Reproductive system and breast disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Menometrorrhagia | Reproductive system and breast disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Metrorrhagia | Reproductive system and breast disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Vaginal discharge | Reproductive system and breast disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Dialysis | Surgical and medical procedures | MedDRA 13.0 | Non-systematic Assessment |
|
| Axillary vein thrombosis | Vascular disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 13.0 | Non-systematic Assessment |
|
| Phlebitis | Vascular disorders | MedDRA 13.0 | Non-systematic Assessment |
|
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.
| D017437 |
| Skin and Connective Tissue Diseases |