Patient's Anastrozole Compliance to Therapy Programme - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00555867

Purpose

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.

Condition	Intervention
Breast Cancer	Drug: Anastrozole

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Anastrozole

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Compliance rate and persistence rate [ Time Frame: until discontinuation of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to treatment discontinuation [ Time Frame: date of last intake of anastrozole minus date of first prescription of anastrozole + 1 ] [ Designated as safety issue: No ]
Demographics and other baseline characteristics as well as information regarding concomitant medication, quality of life [ Time Frame: until treatment discontinuation ] [ Designated as safety issue: No ]
The percentage number of patients with disease free survival [ Time Frame: after 12 months ] [ Designated as safety issue: No ]
Time of disease free survival [ Time Frame: date of recurrence or progression of the tumor minus date of primary breast cancer surgery + 1 ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	4674
Study Start Date:	October 2006
Estimated Study Completion Date:	June 2014

Groups/Cohorts	Assigned Interventions
1 Standard routine care for breast cancer	Drug: Anastrozole oral
2 Standard + Intervention arm: standard routine care for breast cancer and additional information material via post	Drug: Anastrozole oral

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00555867

Contacts

Contact: AstraZeneca Germany Clinical Study, Information

+49 4103-708-3814

brigette.gutendorf@astrazeneca.com

Show 150 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Germany Medical Director

AstraZeneca

More Information

Study ID Numbers:	1033GR/0002
Study First Received:	November 7, 2007
Last Updated:	July 1, 2008
ClinicalTrials.gov Identifier:	NCT00555867
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AstraZeneca:

hormone-receptor positive primary breast cancer
compliance
Postmenopausal women

Study placed in the following topic categories:

Anastrozole
Skin Diseases
Breast Neoplasms
Menopause
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Aromatase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009