Arimidex: Compliance and Arthralgias in Clinical Therapy (COMPACT)
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Purpose
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.
| Condition |
|---|
|
Breast Cancer |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | 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 |
- 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. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- 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. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- Retrospective assessment of incidence of pre-existing arthralgias before start of anastrozole treatment, stratified by upfront and switch therapy. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
- Descriptive assessment of arthralgia therapy and of costs of arthralgia therapy, stratified by upfront and switch therapy. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Identification of factors influencing and correlating to treatment-emergent arthralgias [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Assessment of safety and tolerability of anastrozole. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 2313 |
| Study Start Date: | April 2009 |
| Study Completion Date: | February 2011 |
| Groups/Cohorts |
|---|
|
All patients
treated with Anastrozole as per SPC
|
Detailed Description:
The patient population will include postmenopausal women with hormone-receptor positive primary breast cancer scheduled for adjuvant upfront endocrine treatment with anastrozole or following two to three years of tamoxifen treatment ("switch") according to the current SmPC (Appendix C). Patients will have taken anastrozole for at least three months and not more than six months before the start of the study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
The patient population will include postmenopausal women with hormone-receptor positive primary breast cancer receiving adjuvant endocrine treatment with anastrozole upfront or following two to three years of tamoxifen therapy ("switch") according to the current SmPC (Appendix C). Patients will have received anastrozole treatment for at least 3 months and up to 6 months before the start of the study.
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
Contacts and Locations
Show 385 Study Locations| Study Director: | H Brasch | AstraZeneca, Germany |
More Information
No publications provided
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00857012 History of Changes |
| Other Study ID Numbers: | NIS-ODE-ARI-2008/1 |
| Study First Received: | March 5, 2009 |
| Last Updated: | July 3, 2012 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Keywords provided by AstraZeneca:
|
Primary early MCa Arimidex |
Additional relevant MeSH terms:
|
Arthralgia Breast Neoplasms Joint Diseases Musculoskeletal Diseases Pain Signs and Symptoms Neoplasms by Site Neoplasms Breast Diseases |
Skin Diseases Anastrozole Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Aromatase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on September 26, 2012
