Patient's Anastrozole Compliance to Therapy Programme (PACT)
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ClinicalTrials.gov Identifier: NCT00555867 |
Recruitment Status
:
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)
First Posted
: November 9, 2007
Last Update Posted
: December 23, 2011
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Condition or disease | Intervention/treatment |
---|---|
Breast Cancer | Drug: Anastrozole |
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 |

Group/Cohort | Intervention/treatment |
---|---|
1
Standard routine care for breast cancer
|
Drug: Anastrozole
oral
Other Names:
|
2
Standard + Intervention arm: standard routine care for breast cancer and additional information material via post
|
Drug: Anastrozole
oral
Other Names:
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- Compliance rate and persistence rate [ Time Frame: until discontinuation of treatment ]
- Time to treatment discontinuation [ Time Frame: 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 [ Time Frame: until treatment discontinuation ]
- The percentage number of patients with disease free survival [ Time Frame: after 12 months ]
- Time of disease free survival [ Time Frame: date of recurrence or progression of the tumor minus date of primary breast cancer surgery + 1 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00555867
Study Director: | AstraZeneca Germany Medical Director | AstraZeneca |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00555867 History of Changes |
Other Study ID Numbers: |
1033GR/0002 |
First Posted: | November 9, 2007 Key Record Dates |
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 |