Patient's Anastrozole Compliance to Therapy Programme (PACT)

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment
Breast Cancer	Drug: Anastrozole

Study Design

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Observational
Actual Enrollment :	4923 participants
Observational Model:	Cohort
Time Perspective:	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
Study Start Date :	October 2006
Actual Primary Completion Date :	February 2011
Actual Study Completion Date :	February 2011

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort	Intervention/treatment
1; Standard routine care for breast cancer	Drug: Anastrozole; oral; Other Names: Arimidex; ZD1033
2; Standard + Intervention arm: standard routine care for breast cancer and additional information material via post	Drug: Anastrozole; oral; Other Names: Arimidex; ZD1033

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Compliance rate and persistence rate [ Time Frame: until discontinuation of treatment ]

Secondary Outcome Measures :

1. Time to treatment discontinuation [ Time Frame: date of last intake of anastrozole minus date of first prescription of anastrozole + 1 ]
2. Demographics and other baseline characteristics as well as information regarding concomitant medication, quality of life [ Time Frame: until treatment discontinuation ]
3. The percentage number of patients with disease free survival [ Time Frame: after 12 months ]
4. Time of disease free survival [ Time Frame: date of recurrence or progression of the tumor minus date of primary breast cancer surgery + 1 ]

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes 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

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	AstraZeneca Germany Medical Director	AstraZeneca

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Hadji P, Blettner M, Harbeck N, Jackisch C, Lück 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.

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00555867 History of Changes
Other Study ID Numbers:	1033GR/0002
First Posted:	November 9, 2007
Last Update Posted:	December 23, 2011
Last Verified:	December 2011

Keywords provided by AstraZeneca:

hormone-receptor positive primary breast cancer; compliance; Postmenopausal women

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Anastrozole; Antineoplastic Agents, Hormonal; Antineoplastic Agents	Aromatase Inhibitors; Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Estrogen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs