Trial Outcomes & Findings for A Non-Interventional Study With Aromasin® As Adjuvant Treatment Of Invasive Early Breast Cancer (NCT NCT01121549)
NCT ID: NCT01121549
Last Updated: 2014-01-22
Results Overview
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs were graded using National Cancer Institute (NCI)/Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events version 4.0 (CTCAE,v4.0) as Grade 1 (Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated); Grade 2 (Moderate; minimal, local or noninvasive intervention; limiting age-appropriate instrumental activities of daily living \[ADL\]); Grade 3 (Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization; disabling; limiting self-care ADL); Grade 4 (Life-threatening; urgent intervention indicated) and Grade 5 (Death related to AE).
TERMINATED
378 participants
Baseline up to 28 days after last dose
2014-01-22
Participant Flow
All participants were recruited from Romania.
Participant milestones
| Measure |
Exemestane
Participants with 2 to 3 years of initial adjuvant tamoxifen therapy received exemestane (Aromasin) 25 milligram (mg) tablet orally once daily as per local standard of care to complete 5 years of adjuvant hormonal therapy.
|
|---|---|
|
Overall Study
STARTED
|
378
|
|
Overall Study
COMPLETED
|
31
|
|
Overall Study
NOT COMPLETED
|
347
|
Reasons for withdrawal
| Measure |
Exemestane
Participants with 2 to 3 years of initial adjuvant tamoxifen therapy received exemestane (Aromasin) 25 milligram (mg) tablet orally once daily as per local standard of care to complete 5 years of adjuvant hormonal therapy.
|
|---|---|
|
Overall Study
Adverse Event
|
10
|
|
Overall Study
Lack of Efficacy
|
11
|
|
Overall Study
Lost to Follow-up
|
12
|
|
Overall Study
Did not meet entrance criteria
|
9
|
|
Overall Study
Study terminated by sponsor
|
197
|
|
Overall Study
Pregnancy
|
1
|
|
Overall Study
Protocol Violation
|
33
|
|
Overall Study
Withdrawal by Subject
|
16
|
|
Overall Study
Other
|
58
|
Baseline Characteristics
A Non-Interventional Study With Aromasin® As Adjuvant Treatment Of Invasive Early Breast Cancer
Baseline characteristics by cohort
| Measure |
Exemestane
n=378 Participants
Participants with 2 to 3 years of initial adjuvant tamoxifen therapy received exemestane (Aromasin) 25 milligram (mg) tablet orally once daily as per local standard of care to complete 5 years of adjuvant hormonal therapy.
|
|---|---|
|
Age, Continuous
|
58.3 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
378 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Number of Participants With Type of Tumor
Ductal Carcinoma
|
58 participants
n=5 Participants
|
|
Number of Participants With Type of Tumor
Lobular Carcinoma
|
4 participants
n=5 Participants
|
|
Number of Participants With Type of Tumor
Invasive Ductal Carcinoma
|
246 participants
n=5 Participants
|
|
Number of Participants With Type of Tumor
Invasive Lobular Carcinoma
|
22 participants
n=5 Participants
|
|
Number of Participants With Type of Tumor
Papillary Carcinoma
|
2 participants
n=5 Participants
|
|
Number of Participants With Type of Tumor
Medullary Carcinoma
|
1 participants
n=5 Participants
|
|
Number of Participants With Type of Tumor
Mucinous (Colloid) Carcinoma
|
5 participants
n=5 Participants
|
|
Number of Participants With Type of Tumor
Other
|
24 participants
n=5 Participants
|
|
Number of Participants With Type of Tumor
Missing/No Response
|
16 participants
n=5 Participants
|
|
Number of Participants With Type of Surgery
Appendicectomy
|
6 participants
n=5 Participants
|
|
Number of Participants With Type of Surgery
Breast lump removal
|
1 participants
n=5 Participants
|
|
Number of Participants With Type of Surgery
Cataract operation
|
1 participants
n=5 Participants
|
|
Number of Participants With Type of Surgery
Cholecystectomy
|
17 participants
n=5 Participants
|
|
Number of Participants With Type of Surgery
Hysterectomy
|
3 participants
n=5 Participants
|
|
Number of Participants With Type of Surgery
Intervertebral disc operation
|
1 participants
n=5 Participants
|
|
Number of Participants With Type of Surgery
Malignant tumor excision
|
1 participants
n=5 Participants
|
|
Number of Participants With Type of Surgery
Salpingo-oophorectomy bilateral
|
1 participants
n=5 Participants
|
|
Number of Participants With Type of Surgery
Splenectomy
|
1 participants
n=5 Participants
|
|
Number of Participants With Estrogen Receptor Positive
|
378 participants
n=5 Participants
|
|
Number of Participants With Lymph Node Involvement
|
NA participants
n=5 Participants
|
|
Number of Participants With Tumor Node Metastasis (TNM) Stage
Stage I
|
64 participants
n=5 Participants
|
|
Number of Participants With Tumor Node Metastasis (TNM) Stage
Stage IIA
|
129 participants
n=5 Participants
|
|
Number of Participants With Tumor Node Metastasis (TNM) Stage
Stage IIB
|
92 participants
n=5 Participants
|
|
Number of Participants With Tumor Node Metastasis (TNM) Stage
Stage IIIA
|
67 participants
n=5 Participants
|
|
Number of Participants With Tumor Node Metastasis (TNM) Stage
Stage IIIB
|
16 participants
n=5 Participants
|
|
Number of Participants With Tumor Node Metastasis (TNM) Stage
Stage IIIC
|
2 participants
n=5 Participants
|
|
Number of Participants With Tumor Node Metastasis (TNM) Stage
Other
|
2 participants
n=5 Participants
|
|
Number of Participants With Tumor Node Metastasis (TNM) Stage
Missing/No Response
|
6 participants
n=5 Participants
|
|
Number of Participants With Histopathological Grade
Grade 1
|
62 participants
n=5 Participants
|
|
Number of Participants With Histopathological Grade
Grade 2
|
178 participants
n=5 Participants
|
|
Number of Participants With Histopathological Grade
Grade 3
|
65 participants
n=5 Participants
|
|
Number of Participants With Histopathological Grade
Unknown
|
70 participants
n=5 Participants
|
|
Number of Participants With Histopathological Grade
Missing/No Response
|
3 participants
n=5 Participants
|
|
Number of Participants With Prior Chemotherapy
|
0 participants
n=5 Participants
|
|
Number of Participants With Prior Radiation Therapy
|
239 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline up to 28 days after last dosePopulation: Safety analysis set included all participants who had received at least 1 dose of exemestane during the observation period.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs were graded using National Cancer Institute (NCI)/Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events version 4.0 (CTCAE,v4.0) as Grade 1 (Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated); Grade 2 (Moderate; minimal, local or noninvasive intervention; limiting age-appropriate instrumental activities of daily living \[ADL\]); Grade 3 (Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization; disabling; limiting self-care ADL); Grade 4 (Life-threatening; urgent intervention indicated) and Grade 5 (Death related to AE).
Outcome measures
| Measure |
Exemestane
n=378 Participants
Participants with 2 to 3 years of initial adjuvant tamoxifen therapy received exemestane (Aromasin) 25 milligram (mg) tablet orally once daily as per local standard of care to complete 5 years of adjuvant hormonal therapy.
|
|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) by Severity
Grade 1
|
6 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) by Severity
Grade 2
|
8 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) by Severity
Grade 3
|
6 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) by Severity
Grade 4
|
2 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) by Severity
Grade 5
|
0 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) by Severity
Missing or Unknown
|
2 participants
|
PRIMARY outcome
Timeframe: Baseline up to 28 days after last dosePopulation: Safety analysis set included all participants who had received at least 1 dose of exemestane during the observation period.
An AE (all causalities) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Relatedness to exemestane was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category.
Outcome measures
| Measure |
Exemestane
n=378 Participants
Participants with 2 to 3 years of initial adjuvant tamoxifen therapy received exemestane (Aromasin) 25 milligram (mg) tablet orally once daily as per local standard of care to complete 5 years of adjuvant hormonal therapy.
|
|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) by Relationship to Study Drug
AEs (All Causalities)
|
24 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) by Relationship to Study Drug
SAEs (All Causalities)
|
5 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) by Relationship to Study Drug
AEs (Treatment Related)
|
13 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) by Relationship to Study Drug
SAEs (Treatment Related)
|
0 participants
|
SECONDARY outcome
Timeframe: Week 25, 49, 73, 97, 121, 145Population: Full analysis set (FAS) included all participants who had received at least 1 dose of exemestane during the observation period. 'N' (number of participants analyzed)=participants evaluable for this measure. n=number of participants evaluable at specified time points. None of the participants were evaluable at Week 145 and hence data not reported.
Outcome measures
| Measure |
Exemestane
n=18 Participants
Participants with 2 to 3 years of initial adjuvant tamoxifen therapy received exemestane (Aromasin) 25 milligram (mg) tablet orally once daily as per local standard of care to complete 5 years of adjuvant hormonal therapy.
|
|---|---|
|
Number of Missed Exemestane Doses
Week 25 (n=18)
|
4.9 missed doses
Standard Deviation 7.02
|
|
Number of Missed Exemestane Doses
Week 49 (n=8)
|
9.6 missed doses
Standard Deviation 20.40
|
|
Number of Missed Exemestane Doses
Week 73 (n=5)
|
7.6 missed doses
Standard Deviation 12.54
|
|
Number of Missed Exemestane Doses
Week 97 (n=4)
|
12.3 missed doses
Standard Deviation 13.07
|
|
Number of Missed Exemestane Doses
Week 121 (n=4)
|
6.3 missed doses
Standard Deviation 0.50
|
SECONDARY outcome
Timeframe: Baseline up to Year 3Population: Safety analysis set included all participants who had received at least 1 dose of exemestane during the observation period.
Outcome measures
| Measure |
Exemestane
n=378 Participants
Participants with 2 to 3 years of initial adjuvant tamoxifen therapy received exemestane (Aromasin) 25 milligram (mg) tablet orally once daily as per local standard of care to complete 5 years of adjuvant hormonal therapy.
|
|---|---|
|
Number of Participants With Reasons for Discontinuing Exemestane Therapy
Adverse event
|
10 participants
|
|
Number of Participants With Reasons for Discontinuing Exemestane Therapy
Insufficient clinical response
|
11 participants
|
|
Number of Participants With Reasons for Discontinuing Exemestane Therapy
Did not meet entrance criteria
|
9 participants
|
|
Number of Participants With Reasons for Discontinuing Exemestane Therapy
Lost to follow-up
|
12 participants
|
|
Number of Participants With Reasons for Discontinuing Exemestane Therapy
No longer willing to participate in study
|
16 participants
|
|
Number of Participants With Reasons for Discontinuing Exemestane Therapy
Other unspecified
|
58 participants
|
|
Number of Participants With Reasons for Discontinuing Exemestane Therapy
Protocol violation
|
33 participants
|
|
Number of Participants With Reasons for Discontinuing Exemestane Therapy
Study terminated by sponsor
|
197 participants
|
|
Number of Participants With Reasons for Discontinuing Exemestane Therapy
Withdrawn due to pregnancy
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline up to Year 3Population: FAS included all participants who had received at least 1 dose of exemestane during the observation period.
Outcome measures
| Measure |
Exemestane
n=378 Participants
Participants with 2 to 3 years of initial adjuvant tamoxifen therapy received exemestane (Aromasin) 25 milligram (mg) tablet orally once daily as per local standard of care to complete 5 years of adjuvant hormonal therapy.
|
|---|---|
|
Number of Participants Who Received Hormonal Therapy or Chemotherapy After Discontinuation of Exemestane Therapy
Received hormonal therapy
|
4 participants
|
|
Number of Participants Who Received Hormonal Therapy or Chemotherapy After Discontinuation of Exemestane Therapy
Received chemotherapy
|
319 participants
|
|
Number of Participants Who Received Hormonal Therapy or Chemotherapy After Discontinuation of Exemestane Therapy
Received both hormonal and chemotherapy
|
1 participants
|
|
Number of Participants Who Received Hormonal Therapy or Chemotherapy After Discontinuation of Exemestane Therapy
No hormonal or chemotherapy received
|
34 participants
|
|
Number of Participants Who Received Hormonal Therapy or Chemotherapy After Discontinuation of Exemestane Therapy
Missing or no response
|
20 participants
|
SECONDARY outcome
Timeframe: Baseline up to Year 3Population: Safety analysis set included all participants who had received at least 1 dose of exemestane during the observation period.
Outcome measures
| Measure |
Exemestane
n=378 Participants
Participants with 2 to 3 years of initial adjuvant tamoxifen therapy received exemestane (Aromasin) 25 milligram (mg) tablet orally once daily as per local standard of care to complete 5 years of adjuvant hormonal therapy.
|
|---|---|
|
Percentage of Participants Who Discontinued the Exemestane Therapy
|
91.8 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline up to Year 3Population: A subgroup of participants from FAS who had documented recurrence was evaluable for this measure.
Recurrence-free survival defined as the time from study inclusion to the first date of documented recurrence, with events defined as: local recurrence, distant recurrence, new primary breast cancer (includes both ipsilateral and contralateral second primaries), or death due to any cause. New primary cancer at sites other than the breast were not considered as recurrence.
Outcome measures
| Measure |
Exemestane
n=14 Participants
Participants with 2 to 3 years of initial adjuvant tamoxifen therapy received exemestane (Aromasin) 25 milligram (mg) tablet orally once daily as per local standard of care to complete 5 years of adjuvant hormonal therapy.
|
|---|---|
|
Recurrence-free Survival (RFS)
|
74.357 weeks
Interval 27.14 to 133.57
|
SECONDARY outcome
Timeframe: Baseline up to Year 3Population: Time to disease progression was considered complementary to RFS and hence, was not analyzed.
Time to disease progression was defined as the time from inclusion to first local or distant recurrence at any site.
Outcome measures
Outcome data not reported
Adverse Events
Exemestane
Serious adverse events
| Measure |
Exemestane
n=378 participants at risk
Participants with 2 to 3 years of initial adjuvant tamoxifen therapy received exemestane (Aromasin) 25 milligram (mg) tablet orally once daily as per local standard of care to complete 5 years of adjuvant hormonal therapy.
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.26%
1/378
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.
|
|
Eye disorders
Cataract
|
0.26%
1/378
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.
|
|
Eye disorders
Visual acuity reduced
|
0.26%
1/378
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.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.26%
1/378
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.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.26%
1/378
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.
|
|
Infections and infestations
Pyelonephritis acute
|
0.26%
1/378
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)
Colorectal cancer
|
0.26%
1/378
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)
Meningioma
|
0.26%
1/378
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
Cerebrovascular accident
|
0.26%
1/378
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.
|
|
Respiratory, thoracic and mediastinal disorders
Asthmatic crisis
|
0.26%
1/378
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
Hypertensive crisis
|
0.26%
1/378
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=378 participants at risk
Participants with 2 to 3 years of initial adjuvant tamoxifen therapy received exemestane (Aromasin) 25 milligram (mg) tablet orally once daily as per local standard of care to complete 5 years of adjuvant hormonal therapy.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.3%
5/378
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