Anastrozole Reduced Proliferation and Progesterone Receptor Indexes in Short Term Hormone Therapy

November 18, 2009 updated by: Federal University of São Paulo

Anastrozole Reduced Proliferation and Progesterone Receptor Indexes in Short Term Hormone Therapy. A Prospective Placebo Double Blind Study

Background: Identification of new biomarkers with potential predictive and prognostic role has contributed unequivocally to breast cancer treatment.

Although traditionally endocrine therapy is based on hormonal receptors status (estrogen - ER and progesterone- PR), some patients become hormone resistant. In order to identify a possible profile associated to hormonal resistance, some biomarkers have been assessed after short period primary hormone therapy (HT).

Objectives: To compare the expression of Ki-67, Bcl2, Bax, Bak, ER and e PR in postmenopausal women with ER positive invasive ductal carcinomas (IDC), prior and after tamoxifen and anastrozole in short term hormone therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

71

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 01530020
        • Sao Paulo Federal University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Invasive breast cancer post-menopausal women
  • Estrogen and/or progesterone receptor positive

Exclusion Criteria:

  • Patients with endocrine disease
  • Hormone therapy users or those who had been pregnant in the last 12 months before the diagnosis
  • Patients with a negative expression for estrogen and/or progesterone receptors
  • Women with a history of thromboembolism
  • Patients who had previously undergone any treatment for breast cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Anastrozole
Tamoxifen 20mg and anastrozole 1 mg
OTHER: Tamoxifen
Tamoxifen 20 mg day 26 days
Drug: Anastrozole
Tamoxifen 20mg and anastrozole 1 mg
OTHER: Anastrozole
Anastrozole 1mg 26 days
Drug: Anastrozole
Tamoxifen 20mg and anastrozole 1 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Expression of progesterone
Time Frame: end of the study (june 2008)
end of the study (june 2008)

Secondary Outcome Measures

Outcome Measure
Time Frame
Expression of Ki-67
Time Frame: end of the study (june 2008)
end of the study (june 2008)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of São Paulo

Investigators

  • Principal Investigator: Andre Mattar, MD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (ACTUAL)

July 1, 2007

Study Completion (ACTUAL)

June 1, 2008

Study Registration Dates

First Submitted

November 17, 2009

First Submitted That Met QC Criteria

November 18, 2009

First Posted (ESTIMATE)

November 19, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

November 19, 2009

Last Update Submitted That Met QC Criteria

November 18, 2009

Last Verified

November 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0904/04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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