Breast Neoplasms
Conditions
Keywords
Hormone adjuvant treatment of early breast cancer with aromatase inhibitors following 2-3 years of tamoxifen
Brief summary
This non-interventional study will be conducted in several Eastern European countries to assess the safety, tolerability and efficacy of Aromasin® when it is administered in real-word setting in postmenopausal women with invasive estrogen receptor positive early breast cancer , who are disease-free after completion of 2 to 3 years of tamoxifen and continue the treatment with Aromasin® until completion of 5 years of adjuvant hormonal therapy, to understand how Aromasin® is used in routine clinical practice, to assess adherence to prescribed Aromasin® treatment and to understand reasons for its early discontinuation.
Detailed description
The study prematurely discontinued on October 11, 2011 due to slow enrollment. It should be noted that safety concerns have not been seen in this study and have not factored into this decision.
Interventions
DRUGAromasin
Aromasin® one 25 mg tablet to be taken once daily
Sponsors
Pfizer
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Postmenopausal females, defined as one from the next : 1. Natural menopause ≥1 year, 2. Surgical ovariectomy, 3. Chemotherapy-induced amenorrhoea ≥ 2 years. * Patients who have had surgical treatment for histologically confirmed breast cancer that was non-metastatic at the time of the initial diagnosis. * Patients who are disease-free after 2 to 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 SmPC). * Metastatic breast cancer or a contra lateral tumour. * Other concomitant adjuvant endocrine therapy. * Other 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) | Baseline up to Month 36 | Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness (to study drug) was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Concomitant Medications | Baseline up to Month 36 | 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 | Baseline up to Month 36 | — |
| Number of Participants With Reasons for Discontinuation From Study Medication | Baseline up to Month 36 | — |
| Number of Participants With Concomitant Morbidities | Baseline up to Month 36 | 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. |
| Recurrence-free Survival | Baseline up to Month 36 | Recurrence-free survival defined as the time from the initiation of study medication to the date of confirmation of any recurrence - as local or distant breast cancer recurrence; new primary breast cancer (ipsilateral or contralateral), death due to any cause. |
| Overall Survival | Baseline until death (up to Month 36) | Time in months from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death). |
| Time to Discontinuation | Baseline up to Month 36 | — |
Countries
Croatia, Estonia, Serbia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Exemestane Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred. | 46 |
| Total | 46 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Study terminated by sponsor | 45 |
Baseline characteristics
| Characteristic | Exemestane |
|---|---|
| Age Continuous | 59.0 years STANDARD_DEVIATION 10.7 |
| Concomitant morbidities in the past Cholelithiasis | 1 participants |
| Concomitant morbidities in the past Cystitis noninfective | 1 participants |
| Concomitant morbidities in the past Hypertension | 3 participants |
| Concomitant morbidities in the past Intracranial aneurysm | 1 participants |
| Concomitant morbidities in the past Reproductive tract disorder | 3 participants |
| Histopathological Grade Grade 1 | 10 participants |
| Histopathological Grade Grade 2 | 19 participants |
| Histopathological Grade Grade 3 | 7 participants |
| Histopathological Grade Unknown | 10 participants |
| Hormone Receptor Status | 46 participants |
| Lymph Node Status | NA participants |
| Number of participants on chemotherapy | NA participants |
| Number of participants on radiotherapy | NA participants |
| Sex: Female, Male Female | 46 Participants |
| Sex: Female, Male Male | 0 Participants |
| Tumor Node Metastasis (TNM) Stage Other | 1 participants |
| Tumor Node Metastasis (TNM) Stage Stage I | 18 participants |
| Tumor Node Metastasis (TNM) Stage Stage IIA | 14 participants |
| Tumor Node Metastasis (TNM) Stage Stage IIB | 5 participants |
| Tumor Node Metastasis (TNM) Stage Stage IIIA | 4 participants |
| Tumor Node Metastasis (TNM) Stage Stage IIIB | 4 participants |
| Tumor Node Metastasis (TNM) Stage Stage IIIC | 0 participants |
| Tumor Node Metastasis (TNM) Stage Stage IV | 0 participants |
| Type of Surgery | NA participants |
| Type of Tumor Invasive ductal carcinoma | 31 participants |
| Type of Tumor Invasive lobular carcinoma | 7 participants |
| Type of Tumor Medullary carcinoma | 1 participants |
| Type of Tumor Mucinous (colloid) carcinoma | 2 participants |
| Type of Tumor Other | 5 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 | 2 / 46 |
| serious Total, serious adverse events | 0 / 46 |
Outcome results
Primary
Number of Participants With Adverse Events (AEs)
Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness (to study drug) was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Time frame: Baseline up to Month 36
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) | 2 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: Baseline up to Month 36
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 Concomitant Medications | 0 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: Baseline up to Month 36
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 | 1 participants |
| Exemestane | Number of Participants With Concomitant Morbidities | Glaucoma | 1 participants |
| Exemestane | Number of Participants With Concomitant Morbidities | Scotoma | 1 participants |
| Exemestane | Number of Participants With Concomitant Morbidities | Crohn's disease | 1 participants |
| Exemestane | Number of Participants With Concomitant Morbidities | Fatigue | 1 participants |
| Exemestane | Number of Participants With Concomitant Morbidities | Multiple allergies | 1 participants |
| Exemestane | Number of Participants With Concomitant Morbidities | Skin infection | 1 participants |
| Exemestane | Number of Participants With Concomitant Morbidities | Diabetes mellitus | 1 participants |
| Exemestane | Number of Participants With Concomitant Morbidities | Arthralgia | 2 participants |
| Exemestane | Number of Participants With Concomitant Morbidities | Collagen disorder | 1 participants |
| Exemestane | Number of Participants With Concomitant Morbidities | Intervertebral disc protrusion | 1 participants |
| Exemestane | Number of Participants With Concomitant Morbidities | Osteoporosis | 3 participants |
| Exemestane | Number of Participants With Concomitant Morbidities | Headache | 1 participants |
| Exemestane | Number of Participants With Concomitant Morbidities | Depression | 1 participants |
| Exemestane | Number of Participants With Concomitant Morbidities | Hypertension | 8 participants |
Secondary
Number of Participants With Reasons for Discontinuation From Study Medication
Time frame: Baseline up to Month 36
Population: Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.
Secondary
Overall Survival
Time in months from the start of study treatment to date of death due to any cause. OS was calculated as (the death date minus the date of first dose of study medication plus 1) divided by 30.4. Death was determined from adverse event data (where outcome was death) or from follow-up contact data (where the participant current status was death).
Time frame: Baseline until death (up to Month 36)
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: Baseline up to Month 36
Population: Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.
Secondary
Recurrence-free Survival
Recurrence-free survival defined as the time from the initiation of study medication to the date of confirmation of any recurrence - as local or distant breast cancer recurrence; new primary breast cancer (ipsilateral or contralateral), death due to any cause.
Time frame: Baseline up to Month 36
Population: Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.
Secondary
Time to Discontinuation
Time frame: Baseline up to Month 36
Population: Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.