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Post Marketing Surveillance Study To Observe Safety And Efficacy Of Aromasin In The Patients With Early Or Advanced Breast Cancer


Phase 4
N/A
N/A
Open (Enrolling by invite only)
Female
Breast Cancer

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Trial Information

Post Marketing Surveillance Study To Observe Safety And Efficacy Of Aromasin In The Patients With Early Or Advanced Breast Cancer


All cases at the participating institutions.


Inclusion Criteria:



- Postmenopausal women with breast cancer eligible for hormonal therapy.

Exclusion Criteria:

- Pregnant breast-feeding premenopausal.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

The nature, incidence, duration, and severity of adverse events; discontinuation due to adverse events; outcome and causality will be monitored in this study.

Outcome Time Frame:

adjuvant 1 year ; advanced 6 years

Safety Issue:

Yes

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

Korea: Food and Drug Administration

Study ID:

A5991089

NCT ID:

NCT01047358

Start Date:

August 2010

Completion Date:

July 2014

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

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