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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Other: Aromasin (exemestane)
Aromasin (exemestane), tablets 25 mg, once a day
Other Names:
  • Aromasin, exemestane

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

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.

Helpful Links

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 28, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 1, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 1, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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