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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


N/A
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

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.

Outcome Time Frame:

12 months

Safety Issue:

Yes

Principal Investigator

H Brasch

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca, Germany

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

NIS-ODE-ARI-2008/1

NCT ID:

NCT00857012

Start Date:

April 2009

Completion Date:

February 2012

Related Keywords:

  • Breast Cancer
  • Primary early MCa
  • Arimidex
  • Arthralgia
  • Breast Neoplasms

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