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Arimidex: Compliance and Arthralgias in Clinical Therapy (COMPACT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00857012
First received: March 5, 2009
Last updated: November 9, 2012
Last verified: November 2012
History of Changes
  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

Resource links provided by NLM:

Drug Information available for: Anastrozole
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 2012
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
Study Population

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.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00857012

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Sponsors and Collaborators
AstraZeneca
Investigators
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: November 9, 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 May 22, 2013