Clinical trial · Observational
Arimidex: Compliance and Arthralgias in Clinical Therapy (COMPACT)
Arimidex: Compliance and Arthralgias in Clinical Therapy (COMPACT): An in Practice Assessment of Arthralgias and Related Costs as Well as Compliance in the First Year of Anastrozole Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Patients are eligible for inclusion in this NIS if they have taken anastrozole either upfront or following two to three years of tamoxifen treatment ("switch") for at least three and not more than six months prior to offering an individual participation in this program. Treatment should follow local therapy guidelines and standard practice. Treatment decisions for patients participating in this study including assessments or supportive therapy during follow-up visits will also follow guidelines and remain independent of the program.
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 (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- All patients
- description
- treated with Anastrozole as per SPC
Primary outcomes (1)
- measure
- Assessment of arthralgia scores and patients' compliance within the first year of anastrozole treatment, stratified by upfront and switch therapy as well as assessment of the relationship between compliance and arthralgia scores.
- timeFrame
- 12 months
Secondary outcomes (5)
- measure
- Incidence of arthralgia and arthralgia characteristics within the 1st year of anastrozole therapy stratified by upfront and switch therapy and assessment of the relationship of arthralgia incidence and arthralgia characteristics to patients compliance.
- timeFrame
- 12 months
- measure
- Retrospective assessment of incidence of pre-existing arthralgias before start of anastrozole treatment, stratified by upfront and switch therapy.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Postmenopausal women aged 18 years or older; Postmenopause is defined as Natural menopause with menses \>1 year ago or Serum FSH (\> 20 IU/ l), and E2 levels in the postmenopausal range or patients who had bilateral oophorectomy * Histologically / cytologically confirmed primary diagnosis of early breast cancer (M0) with hormone sensitive tumour (ER+ve and/or PgR+ve) * Patients, who underwent breast cancer surgery and, if appl. radiation therapy and/or neo/adjuvant chemotherapy and have taken adjuvant endocrine treatment with anastrozole (upfront or following two to three years of tamoxifen) min 3 max 6 months * In case of a previous therapy with tamoxifen (switch-therapy), duration of tamoxifen treatment for at least two and up to three years. Exclusion Criteria: * Patients with severe renal function disorders (Creatinine clearance \< 20 ml/min or Patients with moderate or severe disorders of hepatic function * Concomitant treatment with drugs known to affect sex hormonal status and tamoxifen * Patients with ductal carcinoma in situ (DCIS) without primary diagnosis of early breast cancer (M0) * Evidence of any significant clinical disorder or laboratory finding which in the opinion of the investigator, makes it undesirable for the patient to participate in the program
References
Publications (1)
- DERIVEDHadji P, Jackisch C, Bolten W, Blettner M, Hindenburg HJ, Klein P, Konig K, Kreienberg R, Rief W, Wallwiener D, Zaun S, Harbeck N. COMPliance and Arthralgia in Clinical Therapy: the COMPACT trial, assessing the incidence of arthralgia, and compliance within the first year of adjuvant anastrozole therapy. Ann Oncol. 2014 Feb;25(2):372-7. doi: 10.1093/annonc/mdt513. Epub 2013 Dec 18. PMID 24355487