Assessment of Endometrial Changes in Postmenopausal Women With Breast Cancer in Adjuvant Treatment With Anastrozole - Full Text View

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00623519

Purpose

To investigate the global incidence of the endometrial changes in postmenopausal women receiving Anastrozole for the adjuvant treatment of hormone receptors positive breast cancer.

Condition
Breast Cancer

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Anastrozole

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
Official Title:	Assessment of Endometrial Changes in Postmenopausal Women With Breast Cancer in Adjuvant Treatment With Anastrozole.

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Global incidence of endometrial changes during the adjuvant treatment with Anastrozole [ Time Frame: From inclusion to treatment end(5 years duration) measurements will be taken annually, with a further assessment 12 months after end of treatment. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To describe the endometrial changes both clinically(vaginal bleeding) and through the scan. [ Time Frame: During the study, at least annually ] [ Designated as safety issue: No ]
Histological assessment when indicated(type of hyperplasia) [ Time Frame: When applicable ] [ Designated as safety issue: No ]
To assess global incidence of endometrial changes in this patient population before taking Anastrozole [ Time Frame: During the study ] [ Designated as safety issue: No ]
To evaluate type of surgery required for endometrial changes control(hysterectomy rate) [ Time Frame: During the study ] [ Designated as safety issue: No ]
To assess treatment tolerability [ Time Frame: During the study ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	165
Study Start Date:	June 2004
Estimated Study Completion Date:	March 2008
Estimated Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 Women with hormone receptor positive breast cancer under adjuvant treatment with Anastrozole

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Medical Oncology

Criteria

Inclusion Criteria:

Provision of Informed Consent
Resectable breast cancer patients, with histological confirmation
Patients eligible to receive hormonal adjuvant treatment with Anastrozole
They are allowed patients treated with adjuvant chemo or radiotherapy concurrently
Patients previously treated with Tamoxifen that had to withdraw treatment due to other reason than endometrial changes are allowed
Postmenopausal patients(aged 50 years or over/ without menses in the last months/ FSH level >40UI/L / women under 50 years with FSH levels>40UI/L).
Women showing progesterone and/or estrogen receptors positive.

Exclusion Criteria:

Patients with evidence of metastatic disease
Patients unsuitable to receive the medication according the Anastrozole label
Patients not giving their Informed Consent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00623519

Locations

Spain
Research Site
Pontevedra, Spain
Research Site
Coruña, Spain
Research Site
Lugo, Spain
Research Site
Sevilla, Spain
Research Site
Granada, Spain
Research Site
Malaga, Spain
Research Site
La Rioja, Spain
Research Site
Huelva, Spain
Research Site
Mallorca, Spain
Research Site
Ibiza, Spain
Research Site
Santander, Spain
Research Site
Jerez, Spain

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Rosana Cajal, MD

AstraZeneca Spain

More Information

Responsible Party:	AstraZeneca Spain ( Rosana Cajal, MD - Medical Director )
Study ID Numbers:	AST-ANA-2004-01
Study First Received:	February 6, 2008
Last Updated:	December 10, 2008
ClinicalTrials.gov Identifier:	NCT00623519
Health Authority:	Spain: Spanish Agency of Medicines

Keywords provided by AstraZeneca:

Adjuvant postmenopausal breast cancer women

Study placed in the following topic categories:

Anastrozole
Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal
Antineoplastic Agents

Therapeutic Uses
Enzyme Inhibitors
Aromatase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009