APOLLO(Aromatase Inhibitor Patient cOmpLiance Program With qoL Questionaire)

Breast Cancer Clinical Trial

— APOLLO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00523315
• Other study ID #: NIS-OKR-ARI-2007/1
• Status: Completed
• Phase: N/A
• First received: August 30, 2007
• Last updated: May 19, 2011
• Start date: May 2007
• Est. completion date: April 2011

Study information

• Verified date: May 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

To describe patients' compliance of taking Aromatase Inhibitor as an adjuvant treatment in the postmenopausal, early breast cancer as seen under current practice

Recruitment information / eligibility

• Status: Completed
• Enrollment: 862
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
Korea, Republic of	Research Site	Anyang-si	Gyunggi-do
Korea, Republic of	Research Site	Bucheon-si	Gyeonggi-do
Korea, Republic of	Research Site	Busan
Korea, Republic of	Research Site	Cheonan-si	Chuncheongnam-do
Korea, Republic of	Research Site	Daegu
Korea, Republic of	Research Site	Daejeon
Korea, Republic of	Research Site	Daejoen
Korea, Republic of	Reserach Site	Euijungbu-si	Gyunggi-do
Korea, Republic of	Research Site	Goyang-si	Gyeonggi-do
Korea, Republic of	Research Site	Gwangju
Korea, Republic of	Research Site	Iksan-si	Jeollabuk-do
Korea, Republic of	Research Site	Incheon
Korea, Republic of	Research Site	Jeonju	Jeollabuk-do
Korea, Republic of	Research Site	Jinju-si	Gyeongsangnam-do
Korea, Republic of	Research Site	Kangnung-si	Gangwon-do
Korea, Republic of	Research Site	Seongnam	Gyunggi-do
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Suwon	Gyunggi-do
Korea, Republic of	Research Site	Ulsan

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Korea, Republic of, 

External Links

•   Link