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

June 28, 2010
September 25, 2012
September 2010
September 2011   (final data collection date for primary outcome measure)
Number of Participants With Adverse Events (AEs) [ Time Frame: Month 0 up to Month 36 or early withdrawal ] [ Designated as safety issue: Yes ]
An AE was any untoward medical occurrence attributed to study medication in a participant who received study medication.
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01155063 on ClinicalTrials.gov Archive Site
  • Number of Participants With Concomitant Morbidities [ Time Frame: Month 0 up to Month 36 or early withdrawal ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Number of Participants With Reasons for Discontinuation From Study Treatment [ Time Frame: Month 0 up to Month 36 or early withdrawal ] [ Designated as safety issue: No ]
  • Time to Discontinuation of Study Medication [ Time Frame: Month 0 up to Month 36 or early withdrawal ] [ Designated as safety issue: No ]
  • Percentage of Participants With Recurrent Disease [ Time Frame: Month 36 or early withdrawal ] [ Designated as safety issue: No ]
    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).
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • The rate of treatment discontinuation. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • The rate of treatment discontinuation. [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  • The reasons and the timing for discontinuation of Aromasin® therapy. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • The reasons and the timing for discontinuation of Aromasin® therapy. [ Time Frame: 30 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Evaluating The Safety Of Exemestane Following 2-3 Years Of Adjuvant Tamoxifen Therapy In Postmenopausal Early Breast Cancer Patients
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

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Postmenopausal Women With Invasive, Estrogen Receptor Positive Early Breast Cancer Who Are Disease-Free After 2-3 Years Of Initial Adjuvant Tamoxifen Therapy

Early Breast Cancer
Other: Aromasin (exemestane)
Aromasin (exemestane), tablets 25 mg, once a day
Other Name: Aromasin, exemestane
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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
89
September 2011
September 2011   (final data collection date for primary outcome measure)

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.
Female
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01155063
A5991092
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP