Clinical trial NCT00523315: APOLLO(Aromatase Inhibitor Patient cOmpLiance Program With qoL Questionaire)
Official title: A Prospective Observational Study of Compliance in the Patients Receiving Aromatase Inhibitor as an Adjuvant Therapy in Postmenopausal Early Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Aromatase Inhibitor
Breast Cancer
compliance
Naturalistic
Observational
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-08-31
Enrollment: 862
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Department of Surgery or Department of Hemato-oncology in 36 hospitals

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


Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cheonan-si
country: Korea, Republic of
facility: Research Site
state: Chuncheongnam-do
city: Kangnung-si
country: Korea, Republic of
facility: Research Site
state: Gangwon-do
city: Bucheon-si
country: Korea, Republic of
facility: Research Site
state: Gyeonggi-do
city: Goyang-si
country: Korea, Republic of
facility: Research Site
state: Gyeonggi-do
city: Jinju-si
country: Korea, Republic of
facility: Research Site
state: Gyeongsangnam-do
city: Anyang-si
country: Korea, Republic of
facility: Research Site
state: Gyunggi-do
city: Euijungbu-si
country: Korea, Republic of
facility: Reserach Site
state: Gyunggi-do
city: Seongnam
country: Korea, Republic of
facility: Research Site
state: Gyunggi-do
city: Suwon
country: Korea, Republic of
facility: Research Site
state: Gyunggi-do
city: Iksan-si
country: Korea, Republic of
facility: Research Site
state: Jeollabuk-do
city: Jeonju
country: Korea, Republic of
facility: Research Site
state: Jeollabuk-do
city: Busan
country: Korea, Republic of
facility: Research Site
city: Daegu
country: Korea, Republic of
facility: Research Site
city: Daejeon
country: Korea, Republic of
facility: Research Site
city: Daejoen
country: Korea, Republic of
facility: Research Site
city: Gwangju
country: Korea, Republic of
facility: Research Site
city: Incheon
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Ulsan
country: Korea, Republic of
facility: Research Site
Study officials:
affiliation: AstraZeneca Korea
name: Joon Woo Bahn
role: STUDY_DIRECTOR
References: