APOLLO(Aromatase Inhibitor Patient cOmpLiance Program With qoL Questionaire)

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00523315
• Lead Sponsor: AstraZeneca

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-08-30
• Study First Submitted QC: 2007-08-30
• Study First Posted: 2007-08-31
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-19
• Last Update Posted: 2011-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 862

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (2)

Research Site; 🇰🇷 Ulsan, Korea, Republic of

Reserach Site; 🇰🇷 Euijungbu-si, Gyunggi-do, Korea, Republic of