Clinical Trial: Arimidex: Compliance and Arthralgias in Clinical Therapy (COMPACT)

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Arimidex: Compliance and Arthralgias in Clinical Therapy (COMPACT): An in Practice Assessment of Arthralgias and Related Costs as Well as Comp

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 Summary: 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.
Sponsor: AstraZeneca

Current Primary Outcome: 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. [ Time Frame: 12 months ]

Original Primary Outcome: Evaluation of Anastrozole therapy as adjuvant treatment in post.menopausal women with not advanced breast cancer únder naturalistic conditions [ Time Frame: 12 months ]

Current Secondary Outcome:

  • 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. [ Time Frame: 12 months ]
  • Retrospective assessment of incidence of pre-existing arthralgias before start of anastrozole treatment, stratified by upfront and switch therapy. [ Time Frame: 12 months ]
  • Descriptive assessment of arthralgia therapy and of costs of arthralgia therapy, stratified by upfront and switch therapy. [ Time Frame: 12 months ]
  • Identification of factors influencing and correlating to treatment-emergent arthralgias [ Time Frame: 12 months ]
  • Assessment of safety and tolerability of anastrozole. [ Time Frame: 12 months ]


Original Secondary Outcome:

  • Description of population treated with anastrozole [ Time Frame: 12 months ]
  • Further information about the change of specific laboratory parameters [ Time Frame: 12 months ]


Information By: AstraZeneca

Dates:
Date Received: March 5, 2009
Date Started: April 2009
Date Completion:
Last Updated: November 9, 2012
Last Verified: November 2012