Clinical trial · Observational
Patient's Anastrozole Compliance to Therapy Programme
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): 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
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anastrozole | Drug | Anastrozole | ALIAS |
Design
Arms and outcomes
Arms (2)
- label
- 1
- description
- Standard routine care for breast cancer
- interventionNames
- Drug: Anastrozole
- label
- 2
- description
- Standard + Intervention arm: standard routine care for breast cancer and additional information material via post
- interventionNames
- Drug: Anastrozole
Primary outcomes (1)
- measure
- Compliance rate and persistence rate
- timeFrame
- until discontinuation of treatment
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDHadji 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. PMID 23378537