Clinical trial NCT01155063: 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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Early Breast Cancer
Keywords: Exemestane
Adjuvant Treatment In Postmenopausal Women
Estrogen Receptor Positive Early Breast Cancer
Tamoxifen
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-07-01
Enrollment: 89
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

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.

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Month 0 up to Month 36 or early withdrawal
Secondary outcomes:
measure: Number of Participants With Concomitant Morbidities
timeFrame: Month 0 up to Month 36 or early withdrawal
measure: Number of Participants With Concomitant Medications
timeFrame: Month 0 up to Month 36 or early withdrawal
measure: Percentage of Participants Who Discontinued the Study Medication
timeFrame: Month 0 up to Month 36 or early withdrawal
measure: Number of Participants With Reasons for Discontinuation From Study Treatment
timeFrame: Month 0 up to Month 36 or early withdrawal
measure: Time to Discontinuation of Study Medication
timeFrame: Month 0 up to Month 36 or early withdrawal
measure: Percentage of Participants With Recurrent Disease
timeFrame: Month 36 or early withdrawal
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: