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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


N/A
18 Years
60 Years
Not Enrolling
Female
Early Breast Cancer

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Trial Information

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


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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

Number of Participants With Adverse Events (AEs)

Outcome Description:

An AE was any untoward medical occurrence attributed to study medication in a participant who received study medication.

Outcome Time Frame:

Month 0 up to Month 36 or early withdrawal

Safety Issue:

Yes

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

Russia: Central Ethic Committee

Study ID:

A5991092

NCT ID:

NCT01155063

Start Date:

September 2010

Completion Date:

September 2011

Related Keywords:

  • Early Breast Cancer
  • Exemestane
  • Adjuvant Treatment In Postmenopausal Women
  • Estrogen Receptor Positive Early Breast Cancer
  • Tamoxifen
  • Breast Neoplasms

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