Status:
COMPLETED
Arimidex: Compliance and Arthralgias in Clinical Therapy (COMPACT)
Lead Sponsor:
AstraZeneca
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
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...
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 th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
2313 Patients enrolled
Trial Details
Trial ID
NCT00857012
Start Date
April 1 2009
End Date
February 1 2012
Last Update
November 12 2012
Active Locations (383)
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1
Research Site
Aachen, Germany, Germany
2
Research Site
Aalen, Germany, Germany
3
Research Site
Ahaus, Germany, Germany
4
Research Site
Albstadt, Germany, Germany