Arimidex: Compliance and Arthralgias in Clinical Therapy (COMPACT)

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00857012
• Lead Sponsor: AstraZeneca

Brief Summary

Patients are eligible for inclusion in this NIS if they have taken anastrozole either upfront or following two to three years of tamoxifen treatment ("switch") for at least three and not more than six months prior to offering an individual participation in this program. Treatment should follow local therapy guidelines and standard practice. Treatment decisions for patients participating in this study including assessments or supportive therapy during follow-up visits will also follow guidelines and remain independent of the program.

Detailed Description

The patient population will include postmenopausal women with hormone-receptor positive primary breast cancer scheduled for adjuvant upfront endocrine treatment with anastrozole or following two to three years of tamoxifen treatment ("switch") according to the current SmPC (Appendix C). Patients will have taken anastrozole for at least three months and not more than six months before the start of the study.

Study Timeline

• Study First Submitted: 2009-03-05
• Study First Submitted QC: 2009-03-05
• Study First Posted: 2009-03-06
• Study Start: 2009-04
• Study Completion: 2012-02
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-09
• Last Update Posted: 2012-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2313

Inclusion Criteria

• Postmenopausal women aged 18 years or older; Postmenopause is defined as Natural menopause with menses >1 year ago or Serum FSH (> 20 IU/ l), and E2 levels in the postmenopausal range or patients who had bilateral oophorectomy
• Histologically / cytologically confirmed primary diagnosis of early breast cancer (M0) with hormone sensitive tumour (ER+ve and/or PgR+ve)
• Patients, who underwent breast cancer surgery and, if appl. radiation therapy and/or neo/adjuvant chemotherapy and have taken adjuvant endocrine treatment with anastrozole (upfront or following two to three years of tamoxifen) min 3 max 6 months
• In case of a previous therapy with tamoxifen (switch-therapy), duration of tamoxifen treatment for at least two and up to three years.

Exclusion Criteria

• Patients with severe renal function disorders (Creatinine clearance < 20 ml/min or Patients with moderate or severe disorders of hepatic function
• Concomitant treatment with drugs known to affect sex hormonal status and tamoxifen
• Patients with ductal carcinoma in situ (DCIS) without primary diagnosis of early breast cancer (M0)
• Evidence of any significant clinical disorder or laboratory finding which in the opinion of the investigator, makes it undesirable for the patient to participate in the program

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of arthralgia scores and patients' compliance within the first year of anastrozole treatment, stratified by upfront and switch therapy as well as assessment of the relationship between compliance and arthralgia scores.	12 months

Secondary Outcome Measures

Name	Time	Method
Incidence of arthralgia and arthralgia characteristics within the 1st year of anastrozole therapy stratified by upfront and switch therapy and assessment of the relationship of arthralgia incidence and arthralgia characteristics to patients compliance.	12 months
Retrospective assessment of incidence of pre-existing arthralgias before start of anastrozole treatment, stratified by upfront and switch therapy.	12 months
Descriptive assessment of arthralgia therapy and of costs of arthralgia therapy, stratified by upfront and switch therapy.	12 months
Identification of factors influencing and correlating to treatment-emergent arthralgias	12 months
Assessment of safety and tolerability of anastrozole.	12 months

Trial Locations

Locations (1)

Research Site; 🇩🇪 Zwonitz, Germany