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Evaluating The Safety Of Exemestane Following 2-3 Years Of Adjuvant Tamoxifen Therapy In Postmenopausal Early Breast Cancer Patients

This study has been terminated.
(See Detailed Description)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01155063
First received: June 28, 2010
Last updated: September 25, 2012
Last verified: September 2012
History of Changes
Results First Received: August 17, 2012  
Study Type: Observational
Study Design: Observational Model: Case Control;   Time Perspective: Prospective
Condition: Early Breast Cancer
Intervention: Other: Aromasin (exemestane)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Exemestane  
STARTED     89  
COMPLETED     0  
NOT COMPLETED     89  
Adverse Event                 1  
Withdrawal by Subject                 1  
Study terminated by sponsor                 87  



  Baseline Characteristics
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Reporting Groups
  Description
Exemestane 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.

Baseline Measures
    Exemestane  
Number of Participants  
[units: participants]
 		  89  
Age  
[units: Years]
Mean ± Standard Deviation 		  59.2  ± 7.3  
Gender  
[units: Participants]
 		 
Female     89  
Male     0  
Type of Tumor [1]
[units: Participants]
 		 
Ductal carcinoma     5  
Lobular carcinoma     6  
Invasive ductal carcinoma     50  
Invasive lobular carcinoma     20  
Papillary carcinoma     0  
Medullary carcinoma     5  
Mucinous (colloid) carcinoma     2  
Other     1  
Type of Surgery [2]
[units: Participants]
 		  NA [3]
Hormone Receptor Status [4]
[units: Participants]
 		 
Estrogen receptor: Positive     87  
Estrogen receptor: Negative     1  
Estrogen receptor: Unknown     1  
Progesterone receptor: Positive     84  
Progesterone receptor: Negative     4  
Progesterone receptor: Unknown     1  
Lymph Node Status  
[units: Participants]
 		  NA [3]
Tumor Node Metastasis (TNM) Stage [5]
[units: Participants]
 		 
Stage I     20  
Stage IIA     42  
Stage IIB     13  
Stage IIIB     8  
Stage IV     0  
Stage IIIA     4  
Stage IIIC     2  
Histopathological Grade [6]
[units: Participants]
 		 
Grade 1     16  
Grade 2     43  
Grade 3     5  
Grade 4     0  
Unknown     25  
Number of participants on chemotherapy [7]
[units: Participants]
 		  NA [3]
Number of participants on radiotherapy [8]
[units: Participants]
 		  NA [3]
Concomitant morbidities in the past [9]
[units: Participants]
 		 
Myocardial infarction     2  
Thyroid disorder     1  
Cholecystitis     1  
Drug hypersensitivity     1  
Lipid metabolism disorder     1  
Rheumatic fever     1  
Neoplasm malignant     1  
Rectal cancer     1  
Reproductive tract disorder     19  
Hypertension     2  
[1] 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.
[2] Number of participants who had undergone different type of surgeries which included mammectomy, radical resection, radical mastectomy, mastectomy, mammectomy with lymphadenectomy, ovariectomy, mammectomy with lymph node dissection, mastectomy type madden of mammary gland.
[3] Data for this pre-specified outcome measure was collected and reported in individual participant listings but not statistically summarized for analysis.
[4] Number of participants with positive or negative estrogen and progesterone receptors.
[5] 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.
[6] 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).
[7] Number of participants who received chemotherapy. Chemotherapeutic drugs included cyclophosphamide, doxorubicin, 5-fluorouracil, paclitaxel, epirubicin, fluorouracil.
[8] Number of participants who received radiotherapy as measured in radiations per centigray (Rads/cGy).
[9] Participants who had a concomitant morbidity in the past; participants with more than one concomitant co-morbidity were counted for each of the co-morbidity classes applicable.



  Outcome Measures
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1.  Primary:   Number of Participants With Adverse Events (AEs)   [ Time Frame: Month 0 up to Month 36 or early withdrawal ]
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2.  Secondary:   Number of Participants With Concomitant Morbidities   [ Time Frame: Month 0 up to Month 36 or early withdrawal ]
  Show Outcome Measure 2

3.  Secondary:   Number of Participants With Concomitant Medications   [ Time Frame: Month 0 up to Month 36 or early withdrawal ]
  Show Outcome Measure 3

4.  Secondary:   Percentage of Participants Who Discontinued the Study Medication   [ Time Frame: Month 0 up to Month 36 or early withdrawal ]
  Show Outcome Measure 4

5.  Secondary:   Number of Participants With Reasons for Discontinuation From Study Treatment   [ Time Frame: Month 0 up to Month 36 or early withdrawal ]
  Show Outcome Measure 5

6.  Secondary:   Time to Discontinuation of Study Medication   [ Time Frame: Month 0 up to Month 36 or early withdrawal ]
  Show Outcome Measure 6

7.  Secondary:   Percentage of Participants With Recurrent Disease   [ Time Frame: Month 36 or early withdrawal ]
  Show Outcome Measure 7


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study was prematurely discontinued, therefore not all data was analyzed and only one outcome measure timeframe was presented.  


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided


Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01155063     History of Changes
Other Study ID Numbers: A5991092
Study First Received: June 28, 2010
Results First Received: August 17, 2012
Last Updated: September 25, 2012
Health Authority: Russia: Central Ethic Committee