Early Breast Cancer
Conditions
Keywords
Exemestane, Adjuvant Treatment In Postmenopausal Women, Estrogen Receptor Positive Early Breast Cancer, Tamoxifen
Brief summary
Evaluating the safety, tolerability and efficacy of Aromasin® when used in routine clinical practice, evaluating adherence to prescribed Aromasin® treatment and to understand reasons for early discontinuation.
Detailed description
This study was terminated on 01-Aug-2011 due to very low potential to enroll planned number of patients or any sufficient number of patients for complete statistical analyses. This study is not being terminated because of safety or efficacy concerns.
Interventions
Aromasin (exemestane), tablets 25 mg, once a day
Sponsors
Pfizer
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Postmenopausal females. * Patients who have had surgical treatment for histological confirmed breast cancer that was non-metastatic at the time of the initial diagnosis. * Patients who are disease-free after 2 or 3 years of adjuvant tamoxifen treatment. * Patients whose tumour was estrogen receptor positive (ER+). * Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
Exclusion criteria
* Patients for whom Aromasin® treatment is contraindicated (see SPC). * Presence of metastasis or a contra lateral tumour. * Other adjuvant endocrine therapy. * Another concomitant antineoplastic treatment. * 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 |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | Month 0 up to Month 36 or early withdrawal | An AE was any untoward medical occurrence attributed to study medication in a participant who received study medication. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Concomitant Medications | Month 0 up to Month 36 or early withdrawal | Concomitant medication (any medication other than, and in addition to, the study medication) taken for any period of time during the study and was coded by World Health Organization (WHO) medical dictionary. |
| Percentage of Participants Who Discontinued the Study Medication | Month 0 up to Month 36 or early withdrawal | — |
| Number of Participants With Concomitant Morbidities | Month 0 up to Month 36 or early withdrawal | Participants who had a concomitant morbidity during the study for any period of time; participants with more than one concomitant morbidity were counted for each of the concomitant morbidity classes applicable. |
| Time to Discontinuation of Study Medication | Month 0 up to Month 36 or early withdrawal | — |
| Percentage of Participants With Recurrent Disease | Month 36 or early withdrawal | Percentage of participants with confirmed recurrent disease at the end of the study (recurrence was defined as loco-regional and/or contralateral and/or distance metastases). |
| Number of Participants With Reasons for Discontinuation From Study Treatment | Month 0 up to Month 36 or early withdrawal | — |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Exemestane Participants with 2-3 years of initial adjuvant tamoxifen therapy who received exemestane (Aromasin) 25 mg oral tablet once daily to complete 5 years of adjuvant hormonal therapy. | 89 |
| Total | 89 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Study terminated by sponsor | 87 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Exemestane |
|---|---|
| Age Continuous | 59.2 Years STANDARD_DEVIATION 7.3 |
| Concomitant morbidities in the past Cholecystitis | 1 Participants |
| Concomitant morbidities in the past Drug hypersensitivity | 1 Participants |
| Concomitant morbidities in the past Hypertension | 2 Participants |
| Concomitant morbidities in the past Lipid metabolism disorder | 1 Participants |
| Concomitant morbidities in the past Myocardial infarction | 2 Participants |
| Concomitant morbidities in the past Neoplasm malignant | 1 Participants |
| Concomitant morbidities in the past Rectal cancer | 1 Participants |
| Concomitant morbidities in the past Reproductive tract disorder | 19 Participants |
| Concomitant morbidities in the past Rheumatic fever | 1 Participants |
| Concomitant morbidities in the past Thyroid disorder | 1 Participants |
| Histopathological Grade Grade 1 | 16 Participants |
| Histopathological Grade Grade 2 | 43 Participants |
| Histopathological Grade Grade 3 | 5 Participants |
| Histopathological Grade Grade 4 | 0 Participants |
| Histopathological Grade Unknown | 25 Participants |
| Hormone Receptor Status Estrogen receptor: Negative | 1 Participants |
| Hormone Receptor Status Estrogen receptor: Positive | 87 Participants |
| Hormone Receptor Status Estrogen receptor: Unknown | 1 Participants |
| Hormone Receptor Status Progesterone receptor: Negative | 4 Participants |
| Hormone Receptor Status Progesterone receptor: Positive | 84 Participants |
| Hormone Receptor Status Progesterone receptor: Unknown | 1 Participants |
| Lymph Node Status | NA Participants |
| Number of participants on chemotherapy | NA Participants |
| Number of participants on radiotherapy | NA Participants |
| Sex: Female, Male Female | 89 Participants |
| Sex: Female, Male Male | 0 Participants |
| Tumor Node Metastasis (TNM) Stage Stage I | 20 Participants |
| Tumor Node Metastasis (TNM) Stage Stage IIA | 42 Participants |
| Tumor Node Metastasis (TNM) Stage Stage IIB | 13 Participants |
| Tumor Node Metastasis (TNM) Stage Stage IIIA | 4 Participants |
| Tumor Node Metastasis (TNM) Stage Stage IIIB | 8 Participants |
| Tumor Node Metastasis (TNM) Stage Stage IIIC | 2 Participants |
| Tumor Node Metastasis (TNM) Stage Stage IV | 0 Participants |
| Type of Surgery | NA Participants |
| Type of Tumor Ductal carcinoma | 5 Participants |
| Type of Tumor Invasive ductal carcinoma | 50 Participants |
| Type of Tumor Invasive lobular carcinoma | 20 Participants |
| Type of Tumor Lobular carcinoma | 6 Participants |
| Type of Tumor Medullary carcinoma | 5 Participants |
| Type of Tumor Mucinous (colloid) carcinoma | 2 Participants |
| Type of Tumor Other | 1 Participants |
| Type of Tumor Papillary carcinoma | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 6 / 89 |
| serious Total, serious adverse events | 1 / 89 |
Outcome results
Primary
Number of Participants With Adverse Events (AEs)
An AE was any untoward medical occurrence attributed to study medication in a participant who received study medication.
Time frame: Month 0 up to Month 36 or early withdrawal
Population: Safety analysis set included participants who received at least one dose of the study medication during the observation period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Exemestane | Number of Participants With Adverse Events (AEs) | 7 Participants |
Secondary
Number of Participants With Concomitant Medications
Concomitant medication (any medication other than, and in addition to, the study medication) taken for any period of time during the study and was coded by World Health Organization (WHO) medical dictionary.
Time frame: Month 0 up to Month 36 or early withdrawal
Population: Safety analysis set included participants who received at least one dose of the study medication during the observation period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Exemestane | Number of Participants With Concomitant Medications | Acetylsalicylic acid | 4 Participants |
| Exemestane | Number of Participants With Concomitant Medications | Bisoprolol fumarate | 4 Participants |
| Exemestane | Number of Participants With Concomitant Medications | Calcitonin, salmon | 1 Participants |
| Exemestane | Number of Participants With Concomitant Medications | Calcium D3 stada | 2 Participants |
| Exemestane | Number of Participants With Concomitant Medications | Captopril | 1 Participants |
| Exemestane | Number of Participants With Concomitant Medications | Diltiazem | 1 Participants |
| Exemestane | Number of Participants With Concomitant Medications | Durapatite | 1 Participants |
| Exemestane | Number of Participants With Concomitant Medications | Enalapril | 9 Participants |
| Exemestane | Number of Participants With Concomitant Medications | Glibenclamide | 2 Participants |
| Exemestane | Number of Participants With Concomitant Medications | Indapamide | 5 Participants |
| Exemestane | Number of Participants With Concomitant Medications | Inosine | 1 Participants |
| Exemestane | Number of Participants With Concomitant Medications | Levothyroxine sodium | 1 Participants |
| Exemestane | Number of Participants With Concomitant Medications | Loratadine | 1 Participants |
| Exemestane | Number of Participants With Concomitant Medications | Metoprolol tartrate | 1 Participants |
| Exemestane | Number of Participants With Concomitant Medications | Nifedipine | 2 Participants |
| Exemestane | Number of Participants With Concomitant Medications | Penicillin not otherwise specified (NOS) | 1 Participants |
| Exemestane | Number of Participants With Concomitant Medications | Pentaerithrityl tetranitrate | 2 Participants |
| Exemestane | Number of Participants With Concomitant Medications | Suguan | 1 Participants |
| Exemestane | Number of Participants With Concomitant Medications | Tyrosine | 1 Participants |
| Exemestane | Number of Participants With Concomitant Medications | Vinpocetine | 1 Participants |
| Exemestane | Number of Participants With Concomitant Medications | Zoledronic acid | 1 Participants |
Secondary
Number of Participants With Concomitant Morbidities
Participants who had a concomitant morbidity during the study for any period of time; participants with more than one concomitant morbidity were counted for each of the concomitant morbidity classes applicable.
Time frame: Month 0 up to Month 36 or early withdrawal
Population: Safety analysis set included participants who received at least one dose of the study medication during the observation period.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Exemestane | Number of Participants With Concomitant Morbidities | Coronary artery disease | 14 Participants |
| Exemestane | Number of Participants With Concomitant Morbidities | Thyroid disorder | 6 Participants |
| Exemestane | Number of Participants With Concomitant Morbidities | Cholecystitis chronic | 1 Participants |
| Exemestane | Number of Participants With Concomitant Morbidities | Cholelithiasis | 1 Participants |
| Exemestane | Number of Participants With Concomitant Morbidities | Diabetes mellitus | 8 Participants |
| Exemestane | Number of Participants With Concomitant Morbidities | Lipid metabolism disorder | 10 Participants |
| Exemestane | Number of Participants With Concomitant Morbidities | Osteoporosis | 1 Participants |
| Exemestane | Number of Participants With Concomitant Morbidities | Reproductive tract disorder | 11 Participants |
| Exemestane | Number of Participants With Concomitant Morbidities | Hypertension | 37 Participants |
| Exemestane | Number of Participants With Concomitant Morbidities | Varicose vein | 1 Participants |
Secondary
Number of Participants With Reasons for Discontinuation From Study Treatment
Time frame: Month 0 up to Month 36 or early withdrawal
Population: Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.
Secondary
Percentage of Participants Who Discontinued the Study Medication
Time frame: Month 0 up to Month 36 or early withdrawal
Population: Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.
Secondary
Percentage of Participants With Recurrent Disease
Percentage of participants with confirmed recurrent disease at the end of the study (recurrence was defined as loco-regional and/or contralateral and/or distance metastases).
Time frame: Month 36 or early withdrawal
Population: Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.
Secondary
Time to Discontinuation of Study Medication
Time frame: Month 0 up to Month 36 or early withdrawal
Population: Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.