Breast Cancer
Conditions
Keywords
hormone-receptor positive primary breast cancer, compliance, Postmenopausal women
Brief summary
Approximately 60 specialised clinics and 420 office based gynaecologists or oncologists will participate in this in practice evaluation program (NIS). The clinic and approximately 7 office based physicians will collaborate within their breast centre networks to conduct this program. A breast centre network should be able to recruit in this program approximately 80 patients (approximately 40 patients per year). It is planned to enroll approximately 4674 patients in this NIS (2337 patients per arm). The patient population will include postmenopausal women with hormone-receptor positive primary breast cancer scheduled for upfront adjuvant endocrine treatment with anastrozole according to the current standard medical procedures.
Interventions
DRUGAnastrozole
oral
Sponsors
AstraZeneca
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histological/cytological confirmed primary diagnosis of early breast cancer * Postmenopausal * Hormone receptor positive
Exclusion criteria
* Patients with severe renal function disorders * Patients with moderate or severe disorders of hepatic function * Concomitant treatment with drugs known to affect sex hormonal status and tamoxifen
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compliance rate and persistence rate | until discontinuation of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Time to treatment discontinuation | date of last intake of anastrozole minus date of first prescription of anastrozole + 1 |
| Demographics and other baseline characteristics as well as information regarding concomitant medication, quality of life | until treatment discontinuation |
| The percentage number of patients with disease free survival | after 12 months |
| Time of disease free survival | date of recurrence or progression of the tumor minus date of primary breast cancer surgery + 1 |
Outcome results
None listed