Arimidex: Compliance and Arthralgias in Clinical Therapy (COMPACT) - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00857012

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:	Case-Only, 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:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	3212
Study Start Date:	April 2009
Estimated Study Completion Date:	December 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

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

Contacts

Contact: AstraZeneca Clinical Study Information

+49 (0) 800 22 88 66 0

info@astrazeneca.de

Show 326 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

H Brasch

AstraZeneca, Germany

More Information

No publications provided

Responsible Party:	AstraZeneca GmbH ( Dr. Dorothea Jäger )
Study ID Numbers:	NIS-ODE-ARI-2008/1
Study First Received:	March 5, 2009
Last Updated:	June 30, 2009
ClinicalTrials.gov Identifier:	NCT00857012 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AstraZeneca:

Primary early MCa
Arimidex

Study placed in the following topic categories:

Signs and Symptoms
Anastrozole
Antineoplastic Agents, Hormonal
Skin Diseases
Musculoskeletal Diseases
Joint Diseases

Breast Neoplasms
Pain
Aromatase Inhibitors
Arthralgia
Breast Diseases

Additional relevant MeSH terms:

Anastrozole
Molecular Mechanisms of Pharmacological Action
Skin Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Joint Diseases
Breast Neoplasms
Enzyme Inhibitors
Pain

Pharmacologic Actions
Signs and Symptoms
Neoplasms
Neoplasms by Site
Musculoskeletal Diseases
Therapeutic Uses
Aromatase Inhibitors
Arthralgia
Breast Diseases

ClinicalTrials.gov processed this record on September 10, 2009