Trial Outcomes & Findings for Evaluating The Safety Of Exemestane Following 2-3 Years Of Adjuvant Tamoxifen Therapy In Postmenopausal Early Breast Cancer Patients (NCT NCT01155063)
NCT ID: NCT01155063
Last Updated: 2012-10-01
Results Overview
An AE was any untoward medical occurrence attributed to study medication in a participant who received study medication.
Recruitment status
TERMINATED
Target enrollment
89 participants
Primary outcome timeframe
Month 0 up to Month 36 or early withdrawal
Results posted on
2012-10-01
Participant Flow
Participant milestones
| Measure |
Exemestane
Participants with 2-3 years of initial adjuvant tamoxifen therapy who received exemestane (Aromasin) 25 milligram (mg) oral tablet once daily to complete 5 years of adjuvant hormonal therapy.
|
|---|---|
|
Overall Study
STARTED
|
89
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
89
|
Reasons for withdrawal
| Measure |
Exemestane
Participants with 2-3 years of initial adjuvant tamoxifen therapy who received exemestane (Aromasin) 25 milligram (mg) oral tablet once daily to complete 5 years of adjuvant hormonal therapy.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Study terminated by sponsor
|
87
|
Baseline Characteristics
Evaluating The Safety Of Exemestane Following 2-3 Years Of Adjuvant Tamoxifen Therapy In Postmenopausal Early Breast Cancer Patients
Baseline characteristics by cohort
| Measure |
Exemestane
n=89 Participants
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.
|
|---|---|
|
Age Continuous
|
59.2 Years
STANDARD_DEVIATION 7.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
89 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Type of Tumor
Ductal carcinoma
|
5 Participants
n=5 Participants
|
|
Type of Tumor
Lobular carcinoma
|
6 Participants
n=5 Participants
|
|
Type of Tumor
Invasive ductal carcinoma
|
50 Participants
n=5 Participants
|
|
Type of Tumor
Invasive lobular carcinoma
|
20 Participants
n=5 Participants
|
|
Type of Tumor
Papillary carcinoma
|
0 Participants
n=5 Participants
|
|
Type of Tumor
Medullary carcinoma
|
5 Participants
n=5 Participants
|
|
Type of Tumor
Mucinous (colloid) carcinoma
|
2 Participants
n=5 Participants
|
|
Type of Tumor
Other
|
1 Participants
n=5 Participants
|
|
Type of Surgery
|
NA Participants
n=5 Participants
|
|
Hormone Receptor Status
Estrogen receptor: Positive
|
87 Participants
n=5 Participants
|
|
Hormone Receptor Status
Estrogen receptor: Negative
|
1 Participants
n=5 Participants
|
|
Hormone Receptor Status
Estrogen receptor: Unknown
|
1 Participants
n=5 Participants
|
|
Hormone Receptor Status
Progesterone receptor: Positive
|
84 Participants
n=5 Participants
|
|
Hormone Receptor Status
Progesterone receptor: Negative
|
4 Participants
n=5 Participants
|
|
Hormone Receptor Status
Progesterone receptor: Unknown
|
1 Participants
n=5 Participants
|
|
Lymph Node Status
|
NA Participants
n=5 Participants
|
|
Tumor Node Metastasis (TNM) Stage
Stage I
|
20 Participants
n=5 Participants
|
|
Tumor Node Metastasis (TNM) Stage
Stage IIA
|
42 Participants
n=5 Participants
|
|
Tumor Node Metastasis (TNM) Stage
Stage IIB
|
13 Participants
n=5 Participants
|
|
Tumor Node Metastasis (TNM) Stage
Stage IIIB
|
8 Participants
n=5 Participants
|
|
Tumor Node Metastasis (TNM) Stage
Stage IV
|
0 Participants
n=5 Participants
|
|
Tumor Node Metastasis (TNM) Stage
Stage IIIA
|
4 Participants
n=5 Participants
|
|
Tumor Node Metastasis (TNM) Stage
Stage IIIC
|
2 Participants
n=5 Participants
|
|
Histopathological Grade
Grade 1
|
16 Participants
n=5 Participants
|
|
Histopathological Grade
Grade 2
|
43 Participants
n=5 Participants
|
|
Histopathological Grade
Grade 3
|
5 Participants
n=5 Participants
|
|
Histopathological Grade
Grade 4
|
0 Participants
n=5 Participants
|
|
Histopathological Grade
Unknown
|
25 Participants
n=5 Participants
|
|
Number of participants on chemotherapy
|
NA Participants
n=5 Participants
|
|
Number of participants on radiotherapy
|
NA Participants
n=5 Participants
|
|
Concomitant morbidities in the past
Myocardial infarction
|
2 Participants
n=5 Participants
|
|
Concomitant morbidities in the past
Thyroid disorder
|
1 Participants
n=5 Participants
|
|
Concomitant morbidities in the past
Cholecystitis
|
1 Participants
n=5 Participants
|
|
Concomitant morbidities in the past
Drug hypersensitivity
|
1 Participants
n=5 Participants
|
|
Concomitant morbidities in the past
Lipid metabolism disorder
|
1 Participants
n=5 Participants
|
|
Concomitant morbidities in the past
Rheumatic fever
|
1 Participants
n=5 Participants
|
|
Concomitant morbidities in the past
Neoplasm malignant
|
1 Participants
n=5 Participants
|
|
Concomitant morbidities in the past
Rectal cancer
|
1 Participants
n=5 Participants
|
|
Concomitant morbidities in the past
Reproductive tract disorder
|
19 Participants
n=5 Participants
|
|
Concomitant morbidities in the past
Hypertension
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 0 up to Month 36 or early withdrawalPopulation: Safety analysis set included participants who received at least one dose of the study medication during the observation period.
An AE was any untoward medical occurrence attributed to study medication in a participant who received study medication.
Outcome measures
| Measure |
Exemestane
n=89 Participants
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.
|
|---|---|
|
Number of Participants With Adverse Events (AEs)
|
7 Participants
|
SECONDARY outcome
Timeframe: Month 0 up to Month 36 or early withdrawalPopulation: Safety analysis set included participants who received at least one dose of the study medication during the observation period.
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.
Outcome measures
| Measure |
Exemestane
n=89 Participants
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.
|
|---|---|
|
Number of Participants With Concomitant Morbidities
Coronary artery disease
|
14 Participants
|
|
Number of Participants With Concomitant Morbidities
Thyroid disorder
|
6 Participants
|
|
Number of Participants With Concomitant Morbidities
Cholecystitis chronic
|
1 Participants
|
|
Number of Participants With Concomitant Morbidities
Cholelithiasis
|
1 Participants
|
|
Number of Participants With Concomitant Morbidities
Diabetes mellitus
|
8 Participants
|
|
Number of Participants With Concomitant Morbidities
Lipid metabolism disorder
|
10 Participants
|
|
Number of Participants With Concomitant Morbidities
Osteoporosis
|
1 Participants
|
|
Number of Participants With Concomitant Morbidities
Reproductive tract disorder
|
11 Participants
|
|
Number of Participants With Concomitant Morbidities
Hypertension
|
37 Participants
|
|
Number of Participants With Concomitant Morbidities
Varicose vein
|
1 Participants
|
SECONDARY outcome
Timeframe: Month 0 up to Month 36 or early withdrawalPopulation: Safety analysis set included participants who received at least one dose of the study medication during the observation period.
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.
Outcome measures
| Measure |
Exemestane
n=89 Participants
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.
|
|---|---|
|
Number of Participants With Concomitant Medications
Acetylsalicylic acid
|
4 Participants
|
|
Number of Participants With Concomitant Medications
Bisoprolol fumarate
|
4 Participants
|
|
Number of Participants With Concomitant Medications
Calcitonin, salmon
|
1 Participants
|
|
Number of Participants With Concomitant Medications
Calcium D3 "stada"
|
2 Participants
|
|
Number of Participants With Concomitant Medications
Captopril
|
1 Participants
|
|
Number of Participants With Concomitant Medications
Diltiazem
|
1 Participants
|
|
Number of Participants With Concomitant Medications
Durapatite
|
1 Participants
|
|
Number of Participants With Concomitant Medications
Enalapril
|
9 Participants
|
|
Number of Participants With Concomitant Medications
Glibenclamide
|
2 Participants
|
|
Number of Participants With Concomitant Medications
Indapamide
|
5 Participants
|
|
Number of Participants With Concomitant Medications
Inosine
|
1 Participants
|
|
Number of Participants With Concomitant Medications
Levothyroxine sodium
|
1 Participants
|
|
Number of Participants With Concomitant Medications
Loratadine
|
1 Participants
|
|
Number of Participants With Concomitant Medications
Metoprolol tartrate
|
1 Participants
|
|
Number of Participants With Concomitant Medications
Nifedipine
|
2 Participants
|
|
Number of Participants With Concomitant Medications
Penicillin not otherwise specified (NOS)
|
1 Participants
|
|
Number of Participants With Concomitant Medications
Pentaerithrityl tetranitrate
|
2 Participants
|
|
Number of Participants With Concomitant Medications
Suguan
|
1 Participants
|
|
Number of Participants With Concomitant Medications
Tyrosine
|
1 Participants
|
|
Number of Participants With Concomitant Medications
Vinpocetine
|
1 Participants
|
|
Number of Participants With Concomitant Medications
Zoledronic acid
|
1 Participants
|
SECONDARY outcome
Timeframe: Month 0 up to Month 36 or early withdrawalPopulation: Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 0 up to Month 36 or early withdrawalPopulation: Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 0 up to Month 36 or early withdrawalPopulation: Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 36 or early withdrawalPopulation: Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.
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).
Outcome measures
Outcome data not reported
Adverse Events
Exemestane
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Exemestane
n=89 participants at risk
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.
|
|---|---|
|
Infections and infestations
Appendicitis
|
1.1%
1/89
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.
|
Other adverse events
| Measure |
Exemestane
n=89 participants at risk
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.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
1.1%
1/89
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
1.1%
1/89
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.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
1.1%
1/89
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.
|
|
Nervous system disorders
Migraine
|
1.1%
1/89
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.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
1.1%
1/89
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.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.1%
1/89
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.
|
|
Vascular disorders
Hypertension
|
1.1%
1/89
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER