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A Non-Interventional Study With Aromasin® As Adjuvant Treatment Of Invasive Early Breast Cancer

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ClinicalTrials.gov Identifier: NCT01121549
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : May 12, 2010
Results First Posted : January 22, 2014
Last Update Posted : January 22, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Observational
Study Design Time Perspective: Prospective
Condition Invasive Early Breast Cancer
Intervention Drug: Aromasin
Enrollment 378
Recruitment Details All participants were recruited from Romania.
Pre-assignment Details  
Arm/Group Title Exemestane
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 378
Completed 31
Not Completed 347
Reason Not Completed
Adverse Event             10
Lack of Efficacy             11
Lost to Follow-up             12
Did not meet entrance criteria             9
Study terminated by sponsor             197
Pregnancy             1
Protocol Violation             33
Withdrawal by Subject             16
Other             58
Arm/Group Title Exemestane
Hide Arm/Group Description 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 Number of Baseline Participants 378
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 378 participants
58.3  (9.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 378 participants
Female
378
 100.0%
Male
0
   0.0%
Number of Participants With Type of Tumor   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 378 participants
Ductal Carcinoma 58
Lobular Carcinoma 4
Invasive Ductal Carcinoma 246
Invasive Lobular Carcinoma 22
Papillary Carcinoma 2
Medullary Carcinoma 1
Mucinous (Colloid) Carcinoma 5
Other 24
Missing/No Response 16
[1]
Measure Description: Number of participants with different types of tumor such as; ductal carcinoma, lobular carcinoma, invasive ductal carcinoma, invasive lobular carcinoma, papillary carcinoma, medullary carcinoma, mucinous (colloid) carcinoma and others.
Number of Participants With Type of Surgery   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 378 participants
Appendicectomy 6
Breast lump removal 1
Cataract operation 1
Cholecystectomy 17
Hysterectomy 3
Intervertebral disc operation 1
Malignant tumor excision 1
Salpingo-oophorectomy bilateral 1
Splenectomy 1
[1]
Measure Description: Number of participants who had undergone different type of surgeries which included appendicectomy, breast lump removal, cataract operation, cholecystectomy, hysterectomy, intervertebral disc operation, malignant tumor excision, salpingo-oophorectomy bilateral, and splenectomy.
Number of Participants With Estrogen Receptor Positive   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 378 participants
378
[1]
Measure Description: Participants whose tumor was estrogen receptor positive are reported.
Number of Participants With Lymph Node Involvement  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 378 participants
NA [1] 
[1]
Data for this measure could not be analyzed because case report forms did not provide data for accurate assessment of lymph node involvement.
Number of Participants With Tumor Node Metastasis (TNM) Stage   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 378 participants
Stage I 64
Stage IIA 129
Stage IIB 92
Stage IIIA 67
Stage IIIB 16
Stage IIIC 2
Other 2
Missing/No Response 6
[1]
Measure Description: TNM was based on size of tumor, if cancer cells had spread to nearby lymph nodes (LN), or distant (to other parts of the body) metastasis had occurred. Stages included: stage 0(no evidence of cancer cells), stage 1(T1N0M0), stage IIA(T0N1M0, T1N1M0, T2N0M0), stage IIB(T2N1M0, T3N0M0), stage IIIA(T0N2M0, T1N2M0, T2N3M0, T3N1orN2M0), stage IIIC(any TN3M0), stage IV(anyT anyNM1), where T0=early form of tumor, T1= <2 centimeter(cm), T2=2-5 cm, T3= >2 cm, T4=large sized tumor, N0=not spread to LN, N1=spread to 1 to 3, N2=spread to 4 to 9, N3=spread >10 axillary LN, M0=no metastasis, M1= Metastasis.
Number of Participants With Histopathological Grade   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 378 participants
Grade 1 62
Grade 2 178
Grade 3 65
Unknown 70
Missing/No Response 3
[1]
Measure Description: The grade of a cancer depends on what the cells look like and the growth-rate. Lower grade indicates a slower-growing cancer and a higher grade indicates a faster-growing one. Grade 1 (resemble normal cells, not growing rapidly), Grade 2 (grow faster than normal cells), Grade 3 and 4 (abnormal cells, grow and spread aggressively).
Number of Participants With Prior Chemotherapy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 378 participants
0
Number of Participants With Prior Radiation Therapy   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 378 participants
239
[1]
Measure Description: A total 271 participants were evaluable for this measure.
1.Primary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (AEs) by Severity
Hide Description 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).
Time Frame Baseline up to 28 days after last dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who had received at least 1 dose of exemestane during the observation period.
Arm/Group Title Exemestane
Hide Arm/Group Description:
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 Number of Participants Analyzed 378
Measure Type: Number
Unit of Measure: participants
Grade 1 6
Grade 2 8
Grade 3 6
Grade 4 2
Grade 5 0
Missing or Unknown 2
2.Primary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) by Relationship to Study Drug
Hide Description 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.
Time Frame Baseline up to 28 days after last dose
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who had received at least 1 dose of exemestane during the observation period.
Arm/Group Title Exemestane
Hide Arm/Group Description:
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 Number of Participants Analyzed 378
Measure Type: Number
Unit of Measure: participants
AEs (All Causalities) 24
SAEs (All Causalities) 5
AEs (Treatment Related) 13
SAEs (Treatment Related) 0
3.Secondary Outcome
Title Number of Missed Exemestane Doses
Hide Description [Not Specified]
Time Frame Week 25, 49, 73, 97, 121, 145
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Exemestane
Hide Arm/Group Description:
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 Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: missed doses
Week 25 (n=18) 4.9  (7.02)
Week 49 (n=8) 9.6  (20.40)
Week 73 (n=5) 7.6  (12.54)
Week 97 (n=4) 12.3  (13.07)
Week 121 (n=4) 6.3  (0.50)
4.Secondary Outcome
Title Number of Participants With Reasons for Discontinuing Exemestane Therapy
Hide Description [Not Specified]
Time Frame Baseline up to Year 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who had received at least 1 dose of exemestane during the observation period.
Arm/Group Title Exemestane
Hide Arm/Group Description:
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 Number of Participants Analyzed 378
Measure Type: Number
Unit of Measure: participants
Adverse event 10
Insufficient clinical response 11
Did not meet entrance criteria 9
Lost to follow-up 12
No longer willing to participate in study 16
Other unspecified 58
Protocol violation 33
Study terminated by sponsor 197
Withdrawn due to pregnancy 1
5.Secondary Outcome
Title Number of Participants Who Received Hormonal Therapy or Chemotherapy After Discontinuation of Exemestane Therapy
Hide Description [Not Specified]
Time Frame Baseline up to Year 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS included all participants who had received at least 1 dose of exemestane during the observation period.
Arm/Group Title Exemestane
Hide Arm/Group Description:
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 Number of Participants Analyzed 378
Measure Type: Number
Unit of Measure: participants
Received hormonal therapy 4
Received chemotherapy 319
Received both hormonal and chemotherapy 1
No hormonal or chemotherapy received 34
Missing or no response 20
6.Secondary Outcome
Title Percentage of Participants Who Discontinued the Exemestane Therapy
Hide Description [Not Specified]
Time Frame Baseline up to Year 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included all participants who had received at least 1 dose of exemestane during the observation period.
Arm/Group Title Exemestane
Hide Arm/Group Description:
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 Number of Participants Analyzed 378
Measure Type: Number
Unit of Measure: percentage of participants
91.8
7.Secondary Outcome
Title Recurrence-free Survival (RFS)
Hide Description 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.
Time Frame Baseline up to Year 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
A subgroup of participants from FAS who had documented recurrence was evaluable for this measure.
Arm/Group Title Exemestane
Hide Arm/Group Description:
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 Number of Participants Analyzed 14
Median (Full Range)
Unit of Measure: weeks
74.357
(27.14 to 133.57)
8.Secondary Outcome
Title Time to Disease Progression (TTP)
Hide Description Time to disease progression was defined as the time from inclusion to first local or distant recurrence at any site.
Time Frame Baseline up to Year 3
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Time to disease progression was considered complementary to RFS and hence, was not analyzed.
Arm/Group Title Exemestane
Hide Arm/Group Description:
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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description 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.
 
Arm/Group Title Exemestane
Hide Arm/Group Description 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.
All-Cause Mortality
Exemestane
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Exemestane
Affected / at Risk (%)
Total   5/378 (1.32%) 
Cardiac disorders   
Atrial fibrillation * 1  1/378 (0.26%) 
Eye disorders   
Cataract * 1  1/378 (0.26%) 
Visual acuity reduced * 1  1/378 (0.26%) 
Gastrointestinal disorders   
Intestinal obstruction * 1  1/378 (0.26%) 
Hepatobiliary disorders   
Cholelithiasis * 1  1/378 (0.26%) 
Infections and infestations   
Pyelonephritis acute * 1  1/378 (0.26%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Colorectal cancer * 1  1/378 (0.26%) 
Meningioma * 1  1/378 (0.26%) 
Nervous system disorders   
Cerebrovascular accident * 1  1/378 (0.26%) 
Respiratory, thoracic and mediastinal disorders   
Asthmatic crisis * 1  1/378 (0.26%) 
Vascular disorders   
Hypertensive crisis * 1  1/378 (0.26%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Exemestane
Affected / at Risk (%)
Total   5/378 (1.32%) 
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  5/378 (1.32%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.0
The study was prematurely terminated on 31 August 2012 due to unexpected high rate of participant withdrawal caused by Aromasin reimbursement policy change in Romania. There were no safety issues related to study termination.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01121549     History of Changes
Other Study ID Numbers: A5991091
First Submitted: March 30, 2010
First Posted: May 12, 2010
Results First Submitted: December 4, 2013
Results First Posted: January 22, 2014
Last Update Posted: January 22, 2014