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A Prospective Observational Study of Compliance in the Patients Receiving Aromatase Inhibitor as an Adjuvant Therapy in Postmenopausal Early Breast Cancer


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

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Trial Information

A Prospective Observational Study of Compliance in the Patients Receiving Aromatase Inhibitor as an Adjuvant Therapy in Postmenopausal Early Breast Cancer


Inclusion Criteria:



- Provision of written informed consent

- Patients with early breast cancer who are scheduled to receive first-line adjuvant
endocrine therapy with aromatase inhibitor under the routine clinical practice

- Histologically or cytologically proven to be HR+(ER or PR +)

- Postmenopausal woman, defined as a woman fulfilling any of the following criteria(by
the local guideline):

- Age >= 50 years

- Age < 50 years with amenorrhoea > 12 months and an intact uterus

- FSH levels within postmenopausal range (over 30-40 IU/ml), or

- Having undergone a bilateral oophorectomy.

- No other concomitant endocrine therapy such as estrogen therapy or selective
estrogen receptor modulators

Exclusion Criteria:

- Recurrence of breast cancer

- Known hypersensitivity to aromatase inhibitor or to any of the excipients

- Any severe concomitant condition which makes it undesirable for the patient to
participate in the trial or which would jeopardize compliance with the trial protocol

- Previous inclusion in the present study

- Participation in a clinical study during the last 30 days

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Principal Investigator

Joon Woo Bahn

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca Korea

Authority:

Korea: Food and Drug Administration

Study ID:

NIS-OKR-ARI-2007/1

NCT ID:

NCT00523315

Start Date:

May 2007

Completion Date:

April 2011

Related Keywords:

  • Breast Cancer
  • Aromatase Inhibitor
  • Breast Cancer
  • compliance
  • Naturalistic
  • Observational
  • Breast Neoplasms

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