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

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ClinicalTrials.gov Identifier: NCT00857012
Recruitment Status : Completed
First Posted : March 6, 2009
Last Update Posted : November 12, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date March 5, 2009
First Posted Date March 6, 2009
Last Update Posted Date November 12, 2012
Study Start Date April 2009
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: March 10, 2009)
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 Measures
 (submitted: March 5, 2009)
Evaluation of Anastrozole therapy as adjuvant treatment in post.menopausal women with not advanced breast cancer únder naturalistic conditions [ Time Frame: 12 months ]
Change History Complete list of historical versions of study NCT00857012 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 30, 2009)
  • 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 Measures
 (submitted: March 5, 2009)
  • Description of population treated with anastrozole [ Time Frame: 12 months ]
  • Further information about the change of specific laboratory parameters [ Time Frame: 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Arimidex: Compliance and Arthralgias in Clinical Therapy (COMPACT)
Official Title Arimidex: Compliance and Arthralgias in Clinical Therapy (COMPACT): An in Practice Assessment of Arthralgias and Related Costs as Well as Compliance in the First Year of Anastrozole Therapy
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population The patient population will include postmenopausal women with hormone-receptor positive primary breast cancer receiving adjuvant endocrine treatment with anastrozole upfront or following two to three years of tamoxifen therapy ("switch") according to the current SmPC (Appendix C). Patients will have received anastrozole treatment for at least 3 months and up to 6 months before the start of the study.
Condition Breast Cancer
Intervention Not Provided
Study Groups/Cohorts All patients
treated with Anastrozole as per SPC
Publications * Hadji P, Jackisch C, Bolten W, Blettner M, Hindenburg HJ, Klein P, König K, Kreienberg R, Rief W, Wallwiener D, Zaun S, Harbeck N. COMPliance and Arthralgia in Clinical Therapy: the COMPACT trial, assessing the incidence of arthralgia, and compliance within the first year of adjuvant anastrozole therapy. Ann Oncol. 2014 Feb;25(2):372-7. doi: 10.1093/annonc/mdt513. Epub 2013 Dec 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 7, 2011)
2313
Original Estimated Enrollment
 (submitted: March 5, 2009)
3212
Actual Study Completion Date February 2012
Primary Completion Date Not Provided
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT00857012
Other Study ID Numbers NIS-ODE-ARI-2008/1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party AstraZeneca
Study Sponsor AstraZeneca
Collaborators Not Provided
Investigators
Study Director: H Brasch AstraZeneca, Germany
PRS Account AstraZeneca
Verification Date November 2012