Arimidex: Compliance and Arthralgias in Clinical Therapy (COMPACT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00857012
First received: March 5, 2009
Last updated: November 9, 2012
Last verified: November 2012

March 5, 2009
November 9, 2012
April 2009
Not Provided
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 ] [ Designated as safety issue: Yes ]
Evaluation of Anastrozole therapy as adjuvant treatment in post.menopausal women with not advanced breast cancer únder naturalistic conditions [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00857012 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: Yes ]
  • Retrospective assessment of incidence of pre-existing arthralgias before start of anastrozole treatment, stratified by upfront and switch therapy. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Descriptive assessment of arthralgia therapy and of costs of arthralgia therapy, stratified by upfront and switch therapy. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Identification of factors influencing and correlating to treatment-emergent arthralgias [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Assessment of safety and tolerability of anastrozole. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Description of population treated with anastrozole [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Further information about the change of specific laboratory parameters [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Arimidex: Compliance and Arthralgias in Clinical Therapy (COMPACT)
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

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

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.

Breast Cancer
Not Provided
All patients
treated with Anastrozole as per SPC
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.
 
Completed
2313
February 2012
Not Provided

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00857012
NIS-ODE-ARI-2008/1
No
AstraZeneca
AstraZeneca
Not Provided
Study Director: H Brasch AstraZeneca, Germany
AstraZeneca
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP