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Aromasin® As Adjuvant Treatment In Postmenopausal Women With Invasive, Estrogen Receptor Positive Early Breast Cancer

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ClinicalTrials.gov Identifier: NCT01239745
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : November 11, 2010
Results First Posted : October 31, 2012
Last Update Posted : October 31, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Observational
Study Design Observational Model: Case Control;   Time Perspective: Prospective
Condition Breast Neoplasms
Intervention Drug: Aromasin
Enrollment 46
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Exemestane
Hide Arm/Group Description 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.
Period Title: Overall Study
Started 46
Completed 0
Not Completed 46
Reason Not Completed
Study terminated by sponsor             45
Adverse Event             1
Arm/Group Title Exemestane
Hide Arm/Group Description 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.
Overall Number of Baseline Participants 46
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 46 participants
59.0  (10.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants
Female
46
 100.0%
Male
0
   0.0%
Type of Tumor   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 46 participants
Invasive ductal carcinoma 31
Invasive lobular carcinoma 7
Papillary carcinoma 0
Medullary carcinoma 1
Mucinous (colloid) carcinoma 2
Other 5
[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.
Type of Surgery   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 46 participants
NA [2] 
[1]
Measure Description: Number of participants who had undergone different type of surgeries which included mastectomy, axilla evacuation, breast quadrantectomy, dissectio axillae, radical mastectomy, axillary dissection, ablation of both breast, segmentectomy, lymphadenectomy, lumpectomy, core biopsy, sentinel lymph node biopsy, quadrantectomy, re-excision, tumorectomy.
[2]
Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis.
Hormone Receptor Status   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 46 participants
46
[1]
Measure Description: Number of participants with positive estrogen receptors.
Lymph Node Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 46 participants
NA [1] 
[1]
Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis.
Tumor Node Metastasis (TNM) Stage   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 46 participants
Stage I 18
Stage IIA 14
Stage IIB 5
Stage IIIB 4
Stage IV 0
Stage IIIA 4
Stage IIIC 0
Other 1
[1]
Measure Description: TNM:based on tumor size, if cancer cells had spread to nearby lymph nodes (LN), or distant (other parts of body) metastasis. 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 IIIb( T4 anyNM0, any TN3M0),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, 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.
Histopathological Grade   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 46 participants
Grade 1 10
Grade 2 19
Grade 3 7
Unknown 10
[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 on chemotherapy   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 46 participants
NA [2] 
[1]
Measure Description: Number of participants who received chemotherapy. Chemotherapeutic drugs included doxorubicin, cyclophosphamide, docetaxel, fluorouracil, methotrexate , 5-fluorouracil, epirubicin, endoxan, farmorubicin, adriamycin, cytoxan, trastuzumab.
[2]
Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis.
Number of participants on radiotherapy   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 46 participants
NA [2] 
[1]
Measure Description: Number of participants who received radiotherapy as measured in radiations per centigray (Rads/cGy).
[2]
Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis.
Concomitant morbidities in the past   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 46 participants
Cholelithiasis 1
Intracranial aneurysm 1
Cystitis noninfective 1
Reproductive tract disorder 3
Hypertension 3
[1]
Measure Description: Participants who had a concomitant morbidity in the past; participants with more than one concomitant morbidity were counted for each of the concomitant morbidity classes applicable.
1.Primary Outcome
Title Number of Participants With Adverse Events (AEs)
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included participants who received at least one dose of the study medication during the observation period.
Arm/Group Title Exemestane
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 46
Measure Type: Number
Unit of Measure: participants
2
2.Secondary Outcome
Title Number of Participants With Concomitant Morbidities
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included participants who received at least one dose of the study medication during the observation period.
Arm/Group Title Exemestane
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 46
Measure Type: Number
Unit of Measure: participants
Coronary artery disease 1
Glaucoma 1
Scotoma 1
Crohn's disease 1
Fatigue 1
Multiple allergies 1
Skin infection 1
Diabetes mellitus 1
Arthralgia 2
Collagen disorder 1
Intervertebral disc protrusion 1
Osteoporosis 3
Headache 1
Depression 1
Hypertension 8
3.Secondary Outcome
Title Number of Participants With Concomitant Medications
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set included participants who received at least one dose of the study medication during the observation period.
Arm/Group Title Exemestane
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 46
Measure Type: Number
Unit of Measure: participants
0
4.Secondary Outcome
Title Percentage of Participants Who Discontinued the Study Medication
Hide Description [Not Specified]
Time Frame Baseline up to Month 36
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.
Arm/Group Title Exemestane
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Number of Participants With Reasons for Discontinuation From Study Medication
Hide Description [Not Specified]
Time Frame Baseline up to Month 36
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.
Arm/Group Title Exemestane
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Time to Discontinuation
Hide Description [Not Specified]
Time Frame Baseline up to Month 36
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.
Arm/Group Title Exemestane
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Recurrence-free Survival
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.
Arm/Group Title Exemestane
Hide Arm/Group Description:
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.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Overall Survival
Hide Description 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study.
Arm/Group Title Exemestane
Hide Arm/Group Description:
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.
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 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.
All-Cause Mortality
Exemestane
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Exemestane
Affected / at Risk (%)
Total   0/46 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Exemestane
Affected / at Risk (%)
Total   2/46 (4.35%) 
Musculoskeletal and connective tissue disorders   
Musculoskeletal pain * 1  1/46 (2.17%) 
Vascular disorders   
Hot flush * 1  1/46 (2.17%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (14.1)
The study was prematurely discontinued, therefore not all data was analyzed.
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: NCT01239745     History of Changes
Other Study ID Numbers: A5991094
First Submitted: November 3, 2010
First Posted: November 11, 2010
Results First Submitted: October 11, 2012
Results First Posted: October 31, 2012
Last Update Posted: October 31, 2012