- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01155063
Evaluating The Safety Of Exemestane Following 2-3 Years Of Adjuvant Tamoxifen Therapy In Postmenopausal Early Breast Cancer Patients
September 25, 2012 updated by: Pfizer
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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
Enrollment (Actual)
89
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
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
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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
|
Aromasin (exemestane), tablets 25 mg, once a day
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Month 0 up to Month 36 or early withdrawal
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Month 0 up to Month 36 or early withdrawal
|
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.
|
Month 0 up to Month 36 or early withdrawal
|
Percentage of Participants Who Discontinued the Study Medication
Time Frame: Month 0 up to Month 36 or early withdrawal
|
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
|
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
|
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).
|
Month 36 or early withdrawal
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (Actual)
September 1, 2011
Study Completion (Actual)
September 1, 2011
Study Registration Dates
First Submitted
June 28, 2010
First Submitted That Met QC Criteria
June 29, 2010
First Posted (Estimate)
July 1, 2010
Study Record Updates
Last Update Posted (Estimate)
October 1, 2012
Last Update Submitted That Met QC Criteria
September 25, 2012
Last Verified
September 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Hormone Antagonists
- Aromatase Inhibitors
- Steroid Synthesis Inhibitors
- Estrogen Antagonists
- Exemestane
Other Study ID Numbers
- A5991092
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Early Breast Cancer
-
AstraZenecaRecruitingBreast Cancer, Early Breast CancerUnited States, Canada, United Kingdom, China, Argentina, Australia, Hungary, Netherlands, Korea, Republic of, France, Germany, Italy, Belgium, Bulgaria, India, Mexico, Spain, Vietnam, Colombia, Japan, Peru, Brazil, Malaysia, Taiwan, Tha... and more
-
Hoffmann-La RocheCompletedBreast Cancer, Early Breast CancerSerbia
-
University Hospital TuebingenRecruitingAdvanced/Metastatic Breast Cancer | Breast Cancer (Early Breast Cancer)Germany
-
Wake Forest University Health SciencesAtrium Health NavicentActive, not recruitingBreast Cancer Female | Early-stage Breast CancerUnited States
-
Azienda Ospedaliero-Universitaria CareggiRecruitingEarly Breast CancerItaly
-
Novartis PharmaceuticalsTranslational Research in OncologyActive, not recruitingEarly Breast CancerUnited States, Belgium, Canada, Italy, United Kingdom, Hungary, Taiwan, Australia, Germany, Spain, Austria, Russian Federation, Korea, Republic of, China, France, Brazil, Ireland, Argentina, Romania, Poland
-
Spanish Breast Cancer Research GroupEli Lilly and CompanyActive, not recruiting
-
Swiss Group for Clinical Cancer ResearchCompleted
-
ETOP IBCSG Partners FoundationAlliance for Clinical Trials in Oncology; Canadian Cancer Trials Group; Breast...Active, not recruitingEarly Breast CancerKorea, Republic of, United States, France, Canada, Spain, Lebanon, Belgium, Switzerland, Israel, Ireland, Japan, Italy, Denmark, Austria, Australia, Greece, Hungary, Netherlands, Norway, Portugal, Serbia, Slovenia
-
Hoffmann-La RocheCompletedEarly Breast CancerSpain, Korea, Republic of, Australia, Taiwan, Ukraine, Poland, Russian Federation, United States, Germany, Brazil, Hungary
Clinical Trials on Aromasin (exemestane)
-
Actavis Inc.Withdrawn
-
PfizerCompletedPost Menopausal Women With Early Breast Cancer
-
BiogenCompletedBreast CancerUnited States, Russian Federation, Australia, Belgium
-
PfizerCompleted
-
Jules Bordet InstituteNovartisCompleted
-
Roxane LaboratoriesCompletedBreast CancerUnited States
-
Roxane LaboratoriesCompleted
-
PfizerTerminated
-
PfizerCompletedBreast NeoplasmsFrance
-
PfizerCompletedBreast NeoplasmsChina