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

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ClinicalTrials.gov Identifier: NCT01155063
Recruitment Status : Terminated (See Detailed Description)
First Posted : July 1, 2010
Results First Posted : September 20, 2012
Last Update Posted : October 1, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date June 28, 2010
First Posted Date July 1, 2010
Results First Submitted Date August 17, 2012
Results First Posted Date September 20, 2012
Last Update Posted Date October 1, 2012
Study Start Date September 2010
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 17, 2012)
Number of Participants With Adverse Events (AEs) [ Time Frame: Month 0 up to Month 36 or early withdrawal ]
An AE was any untoward medical occurrence attributed to study medication in a participant who received study medication.
Original Primary Outcome Measures
 (submitted: June 29, 2010)
  • Overall Safety profile characterized by type, frequency and severity of adverse events as graded according to the NCI/CTEP CTCAE, v4.0 and their relationship with study therapy. [ Time Frame: 24 months ]
  • Overall Safety profile characterized by type, frequency and severity of adverse events as graded according to the NCI/CTEP CTCAE, v4.0 and their relationship with study therapy. [ Time Frame: 30 months ]
Change History
Current Secondary Outcome Measures
 (submitted: August 17, 2012)
  • Number of Participants With Concomitant Morbidities [ Time Frame: Month 0 up to Month 36 or early withdrawal ]
    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.
  • Number of Participants With Concomitant Medications [ Time Frame: Month 0 up to Month 36 or early withdrawal ]
    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.
  • Percentage of Participants Who Discontinued the Study Medication [ Time Frame: Month 0 up to Month 36 or early withdrawal ]
  • Number of Participants With Reasons for Discontinuation From Study Treatment [ Time Frame: Month 0 up to Month 36 or early withdrawal ]
  • Time to Discontinuation of Study Medication [ Time Frame: Month 0 up to Month 36 or early withdrawal ]
  • Percentage of Participants With Recurrent Disease [ Time Frame: Month 36 or early withdrawal ]
    Percentage of participants with confirmed recurrent disease at the end of the study (recurrence was defined as loco-regional and/or contralateral and/or distance metastases).
Original Secondary Outcome Measures
 (submitted: June 29, 2010)
  • The profile of patients treated with Aromasin® characterized by age, type of tumor, type of surgery, hormone receptors, lymph node involvement, stage, grade, chemotherapy, radiotherapy and concomitant morbidity and treatment. [ Time Frame: 24 months ]
  • The profile of patients treated with Aromasin® characterized by age, type of tumor, type of surgery, hormone receptors, lymph node involvement, stage, grade, chemotherapy, radiotherapy and concomitant morbidity and treatment. [ Time Frame: 30 months ]
  • The rate of treatment discontinuation. [ Time Frame: 24 months ]
  • The rate of treatment discontinuation. [ Time Frame: 30 months ]
  • The reasons and the timing for discontinuation of Aromasin® therapy. [ Time Frame: 24 months ]
  • The reasons and the timing for discontinuation of Aromasin® therapy. [ Time Frame: 30 months ]
  • Recurrence-free survival from the initiation of Aromasin® treatment to the date of confirmation of any recurrence - as local or distant breast cancer recurrence; new primary ipsilateral or contralateral breast cancer, death due to any cause. [ Time Frame: 24 months ]
  • Recurrence-free survival from the initiation of Aromasin® treatment to the date of confirmation of any recurrence - as local or distant breast cancer recurrence; new primary ipsilateral or contralateral breast cancer, death due to any cause. [ Time Frame: 30 months ]
  • Overall survival calculated as the time from the initiation of Aromasin® treatment to the date of death due to any cause. [ Time Frame: 24 months ]
  • Overall survival calculated as the time from the initiation of Aromasin® treatment to the date of death due to any cause. [ Time Frame: 30 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluating The Safety Of Exemestane Following 2-3 Years Of Adjuvant Tamoxifen Therapy In Postmenopausal Early Breast Cancer Patients
Official Title A Non-Interventional Observational Study Evaluating The Effects Of Exemestane Following 2-3 Years Of Adjuvant Tamoxifen Therapy On Safety In Postmenopausal And Hormone Receptors Positive Early Breast Cancer Patients
Brief Summary Evaluating the safety, tolerability and efficacy of Aromasin® when used in routine clinical practice, evaluating adherence to prescribed Aromasin® treatment and to understand reasons for early discontinuation.
Detailed Description This study was terminated on 01-Aug-2011 due to very low potential to enroll planned number of patients or any sufficient number of patients for complete statistical analyses. This study is not being terminated because of safety or efficacy concerns.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Postmenopausal Women With Invasive, Estrogen Receptor Positive Early Breast Cancer Who Are Disease-Free After 2-3 Years Of Initial Adjuvant Tamoxifen Therapy
Condition Early Breast Cancer
Intervention Other: Aromasin (exemestane)
Aromasin (exemestane), tablets 25 mg, once a day
Other Name: Aromasin, exemestane
Study Groups/Cohorts Main Group
Postmenopausal Women With Invasive, Estrogen Receptor Positive Early Breast Cancer Who Are Disease-Free After 2-3 Years Of Initial Adjuvant Tamoxifen Therapy
Intervention: Other: Aromasin (exemestane)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: August 17, 2012)
89
Original Estimated Enrollment
 (submitted: June 29, 2010)
600
Actual Study Completion Date September 2011
Actual Primary Completion Date September 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Postmenopausal females.
  • Patients who have had surgical treatment for histological confirmed breast cancer that was non-metastatic at the time of the initial diagnosis.
  • Patients who are disease-free after 2 or 3 years of adjuvant tamoxifen treatment.
  • Patients whose tumour was estrogen receptor positive (ER+).
  • Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria:

  • Patients for whom Aromasin® treatment is contraindicated (see SPC).
  • Presence of metastasis or a contra lateral tumour.
  • Other adjuvant endocrine therapy.
  • Another concomitant antineoplastic treatment.
  • Participation in a clinical trial with an investigational drug during the 30 days prior to enrolment in the study.
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT01155063
Other Study ID Numbers A5991092
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date September 2012