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Trial record 1 of 1 for:    NCT01239745
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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

Tracking Information
First Submitted Date November 3, 2010
First Posted Date November 11, 2010
Results First Submitted Date October 11, 2012
Results First Posted Date October 31, 2012
Last Update Posted Date October 31, 2012
Study Start Date April 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 11, 2012)
Number of Participants With Adverse Events (AEs) [ Time Frame: Baseline up to Month 36 ]
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.
Original Primary Outcome Measures
 (submitted: November 10, 2010)
Overall Safety profile (6 monthly physical examinations, ECOG, lab examinations and adverse event assessments) [ Time Frame: 51 months ]
Change History Complete list of historical versions of study NCT01239745 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 11, 2012)
  • Number of Participants With Concomitant Morbidities [ Time Frame: Baseline up to Month 36 ]
    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: Baseline up to Month 36 ]
    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: Baseline up to Month 36 ]
  • Number of Participants With Reasons for Discontinuation From Study Medication [ Time Frame: Baseline up to Month 36 ]
  • Time to Discontinuation [ Time Frame: Baseline up to Month 36 ]
  • Recurrence-free Survival [ Time Frame: Baseline up to Month 36 ]
    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.
  • Overall Survival [ Time Frame: Baseline until death (up to Month 36) ]
    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).
Original Secondary Outcome Measures
 (submitted: November 10, 2010)
  • The profile of patients treated with Aromasin characterized by mean age, cell counts, percents for type of tumor, type of surgery, hormone receptors, lymph node involvement, stage, grade, chemotherapy, radiotherapy, concomitant morbidity and treatment. [ Time Frame: 51 months ]
  • The rate of treatment discontinuation. [ Time Frame: 51 months ]
  • The reasons for discontinuation of Aromasin®. [ Time Frame: 51 months ]
  • The timing for discontinuation of Aromasin® . [ Time Frame: 51 months ]
  • Recurrence-free survival. [ Time Frame: 51 months ]
  • Overall survival. [ Time Frame: 51 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Aromasin® As Adjuvant Treatment In Postmenopausal Women With Invasive, Estrogen Receptor Positive Early Breast Cancer
Official Title A Non-Interventional Study With Aromasin® As Adjuvant Treatment In Postmenopausal Women With Invasive, Estrogen Receptor Positive Early Breast Cancer Who Are Disease-Free After 2-3 Years Of Initial Adjuvant Tamoxifen Therapy
Brief Summary This non-interventional study will be conducted in several Eastern European countries to assess the safety, tolerability and efficacy of Aromasin® when it is administered in real-word setting in postmenopausal women with invasive estrogen receptor positive early breast cancer , who are disease-free after completion of 2 to 3 years of tamoxifen and continue the treatment with Aromasin® until completion of 5 years of adjuvant hormonal therapy, to understand how Aromasin® is used in routine clinical practice, to assess adherence to prescribed Aromasin® treatment and to understand reasons for its early discontinuation.
Detailed Description The study prematurely discontinued on October 11, 2011 due to slow enrollment. It should be noted that safety concerns have not been seen in this study and have not factored into this decision.
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 Estrogen receptor positive early breast cancer patients
Condition Breast Neoplasms
Intervention Drug: Aromasin
Aromasin® one 25 mg tablet to be taken once daily
Other Name: Exemestane
Study Groups/Cohorts 1
Intervention: Drug: Aromasin
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: October 11, 2012)
46
Original Estimated Enrollment
 (submitted: November 10, 2010)
350
Actual Study Completion Date October 2011
Actual Primary Completion Date October 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Postmenopausal females, defined as one from the next :

    1. Natural menopause ≥1 year,
    2. Surgical ovariectomy,
    3. Chemotherapy-induced amenorrhoea ≥ 2 years.
  • Patients who have had surgical treatment for histologically confirmed breast cancer that was non-metastatic at the time of the initial diagnosis.
  • Patients who are disease-free after 2 to 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 SmPC).
  • Metastatic breast cancer or a contra lateral tumour.
  • Other concomitant adjuvant endocrine therapy.
  • Other 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 Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Croatia,   Estonia,   Serbia
Removed Location Countries  
 
Administrative Information
NCT Number NCT01239745
Other Study ID Numbers A5991094
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 October 2012