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Completed

NCT Number: NCT01016665

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

40 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sao Paulo Federal University

São Paulo, 01530020, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anastrozole

Drug

Tamoxifen 20mg and anastrozole 1 mg

Primary outcomes

  1. Expression of progesterone

    Time frame: end of the study (june 2008)

Secondary outcomes

  1. Expression of Ki-67

    Time frame: end of the study (june 2008)

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2007
Study completion
2008
First posted
Nov 19, 2009
Registry last updated
Nov 19, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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