Assessment of Endometrial Changes in Postmenopausal Women With Breast Cancer in Adjuvant Treatment With Anastrozole

NCT ID: NCT00623519

Last Updated: 2009-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

165 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-06-30

Study Completion Date

2009-02-28

Brief Summary

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

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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1

Women with hormone receptor positive breast cancer under adjuvant treatment with Anastrozole

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca Spain

Principal Investigators

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Rosana Cajal, MD

Role: STUDY_DIRECTOR

AstraZeneca Spain

Locations

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Research Site

A Coruña, , Spain

Site Status

Research Site

Granada, , Spain

Site Status

Research Site

Huelva, , Spain

Site Status

Research Site

Ibiza Town, , Spain

Site Status

Research Site

Jerez de la Frontera, , Spain

Site Status

Research Site

La Rioja, , Spain

Site Status

Research Site

Lugo, , Spain

Site Status

Research Site

Mallorca, , Spain

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Research Site

Málaga, , Spain

Site Status

Research Site

Pontevedra, , Spain

Site Status

Research Site

Santander, , Spain

Site Status

Research Site

Seville, , Spain

Site Status

Countries

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Spain

Other Identifiers

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AST-ANA-2004-01

Identifier Type: -

Identifier Source: org_study_id

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