Clinical trial NCT00555867: Patient's Anastrozole Compliance to Therapy Programme
Official title: A Randomised in Practice Evaluation of the Influence of Patient's Understanding of Her Disease and Therapy on Persistence and Compliance to Adjuvant Therapy for Post-menopausal Hormone Sensitive Early Breast Cancer
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Breast Cancer
Keywords: hormone-receptor positive primary breast cancer
compliance
Postmenopausal women
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-11-09
Enrollment: 4923
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Postmenopausal women with hormone receptor positive primary breast cancer scheduled for upfront adjuvant endocrine treatment with anastrozole according to the current standard medical practice

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.


Eligibility criteria: 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

Primary outcomes:
measure: Compliance rate and persistence rate
timeFrame: until discontinuation of treatment
Secondary outcomes:
measure: Time to treatment discontinuation
timeFrame: date of last intake of anastrozole minus date of first prescription of anastrozole + 1
measure: Demographics and other baseline characteristics as well as information regarding concomitant medication, quality of life
timeFrame: until treatment discontinuation
measure: The percentage number of patients with disease free survival
timeFrame: after 12 months
measure: Time of disease free survival
timeFrame: date of recurrence or progression of the tumor minus date of primary breast cancer surgery + 1
Other outcomes:
Locations:
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Germany Medical Director
role: STUDY_DIRECTOR
References:
citation: Hadji P, Blettner M, Harbeck N, Jackisch C, Luck HJ, Windemuth-Kieselbach C, Zaun S, Kreienberg R. The Patient's Anastrozole Compliance to Therapy (PACT) Program: a randomized, in-practice study on the impact of a standardized information program on persistence and compliance to adjuvant endocrine therapy in postmenopausal women with early breast cancer. Ann Oncol. 2013 Jun;24(6):1505-12. doi: 10.1093/annonc/mds653. Epub 2013 Feb 1.