APOLLO(Aromatase Inhibitor Patient cOmpLiance Program With qoL Questionaire)

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00523315

Acronym

APOLLO

Enrollment

862

Registered

2007-08-31

Start date

2007-05-31

Completion date

2011-04-30

Last updated

2011-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Aromatase Inhibitor, Breast Cancer, compliance, Naturalistic, Observational

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Countries

South Korea

Outcome results