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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

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 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.

Participant Flow:   Overall Study
    Exemestane
STARTED   46 
COMPLETED   0 
NOT COMPLETED   46 
Study terminated by sponsor                45 
Adverse Event                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Exemestane 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.

Baseline Measures
   Exemestane 
Overall Participants Analyzed 
[Units: Participants]
 46 
Age 
[Units: Years]
Mean (Standard Deviation)
 59.0  (10.7) 
Gender 
[Units: Participants]
 
Female   46 
Male   0 
Type of Tumor [1] 
[Units: Participants]
 
Invasive ductal carcinoma   31 
Invasive lobular carcinoma   7 
Papillary carcinoma   0 
Medullary carcinoma   1 
Mucinous (colloid) carcinoma   2 
Other   5 
[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.
Type of Surgery [1] [2] 
[Units: Participants]
 NA [2] 
[1] 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] 
[Units: Participants]
 46 
[1] Number of participants with positive estrogen receptors.
Lymph Node Status [1] 
[Units: 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] 
[Units: 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] 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] 
[Units: Participants]
 
Grade 1   10 
Grade 2   19 
Grade 3   7 
Unknown   10 
[1] 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] [2] 
[Units: Participants]
 NA [2] 
[1] 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] [2] 
[Units: Participants]
 NA [2] 
[1] 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] 
[Units: Participants]
 
Cholelithiasis   1 
Intracranial aneurysm   1 
Cystitis noninfective   1 
Reproductive tract disorder   3 
Hypertension   3 
[1] 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.


  Outcome Measures

1.  Primary:   Number of Participants With Adverse Events (AEs)   [ Time Frame: Baseline up to Month 36 ]

2.  Secondary:   Number of Participants With Concomitant Morbidities   [ Time Frame: Baseline up to Month 36 ]

3.  Secondary:   Number of Participants With Concomitant Medications   [ Time Frame: Baseline up to Month 36 ]

4.  Secondary:   Percentage of Participants Who Discontinued the Study Medication   [ Time Frame: Baseline up to Month 36 ]

5.  Secondary:   Number of Participants With Reasons for Discontinuation From Study Medication   [ Time Frame: Baseline up to Month 36 ]

6.  Secondary:   Time to Discontinuation   [ Time Frame: Baseline up to Month 36 ]

7.  Secondary:   Recurrence-free Survival   [ Time Frame: Baseline up to Month 36 ]

8.  Secondary:   Overall Survival   [ Time Frame: Baseline until death (up to Month 36) ]


  Serious Adverse Events


  Other Adverse Events


  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.


  More Information

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.


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



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