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Evaluating The Safety Of Exemestane Following 2-3 Years Of Adjuvant Tamoxifen Therapy In Postmenopausal Early Breast Cancer Patients

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ClinicalTrials.gov Identifier: NCT01155063
Recruitment Status : Terminated (See Detailed Description)
First Posted : July 1, 2010
Results First Posted : September 20, 2012
Last Update Posted : October 1, 2012
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment
Early Breast Cancer Other: Aromasin (exemestane)

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
Actual Enrollment : 89 participants
Observational Model: Case Control
Time Perspective: Prospective
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 Start Date : September 2010
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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
Other: Aromasin (exemestane)
Aromasin (exemestane), tablets 25 mg, once a day
Other Name: Aromasin, exemestane




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Percentage of Participants Who Discontinued the Study Medication [ Time Frame: Month 0 up to Month 36 or early withdrawal ]
  4. Number of Participants With Reasons for Discontinuation From Study Treatment [ Time Frame: Month 0 up to Month 36 or early withdrawal ]
  5. Time to Discontinuation of Study Medication [ Time Frame: Month 0 up to Month 36 or early withdrawal ]
  6. 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).



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01155063


Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01155063     History of Changes
Other Study ID Numbers: A5991092
First Posted: July 1, 2010    Key Record Dates
Results First Posted: September 20, 2012
Last Update Posted: October 1, 2012
Last Verified: September 2012

Keywords provided by Pfizer:
Exemestane
Adjuvant Treatment In Postmenopausal Women
Estrogen Receptor Positive Early Breast Cancer
Tamoxifen

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tamoxifen
Exemestane
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action