Patient's Anastrozole Compliance to Therapy Programme (PACT)

This study has been terminated.

(High drop-out rate leads to the conclusion: not enough data will be available to perform proper analyses of data collected after follow-up month 24 visit)

Sponsor:

Information provided by (Responsible Party):

AstraZeneca

ClinicalTrials.gov Identifier:

NCT00555867

First received: November 7, 2007

Last updated: December 22, 2011

Last verified: December 2011

History of Changes

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


Study Type:	Observational
Study Design:	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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer glycogen storage disease type VI

MedlinePlus related topics: Breast Cancer Cancer Hormones

Drug Information available for: Anastrozole

U.S. FDA Resources

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 ]


Enrollment:	4923
Study Start Date:	October 2006
Study Completion Date:	February 2011
Primary Completion Date:	February 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators

AstraZeneca

Investigators


Study Director:	AstraZeneca Germany Medical Director	AstraZeneca

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
Study First Received:	November 7, 2007
Last Updated:	December 22, 2011
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on September 28, 2016

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