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

This study has been completed.
Information provided by:
Federal University of São Paulo Identifier:
First received: November 17, 2009
Last updated: November 18, 2009
Last verified: November 2009

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.

Condition Intervention
Breast Cancer
Drug: Anastrozole

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Basic Science
Official Title: Anastrozole Reduced Proliferation and Progesterone Receptor Indexes in Short Term Hormone Therapy. A Prospective Placebo Double Blind Study

Resource links provided by NLM:

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • Expression of progesterone [ Time Frame: end of the study (june 2008) ]

Secondary Outcome Measures:
  • Expression of Ki-67 [ Time Frame: end of the study (june 2008) ]

Enrollment: 71
Study Start Date: April 2005
Study Completion Date: June 2008
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Drug: Anastrozole
Tamoxifen 20mg and anastrozole 1 mg
Tamoxifen 20 mg day 26 days
Drug: Anastrozole
Tamoxifen 20mg and anastrozole 1 mg
Anastrozole 1mg 26 days
Drug: Anastrozole
Tamoxifen 20mg and anastrozole 1 mg


Ages Eligible for Study:   40 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01016665

Sao Paulo Federal University
Sao Paulo, Brazil, 01530020
Sponsors and Collaborators
Federal University of São Paulo
Principal Investigator: Andre Mattar, MD
  More Information


Responsible Party: Andre Mattar MD, Federal University of Sao Paulo Identifier: NCT01016665     History of Changes
Other Study ID Numbers: 0904/04
Study First Received: November 17, 2009
Last Updated: November 18, 2009

Keywords provided by Federal University of São Paulo:
Breast cancer
Short Term
aromatase inhibitor
Short term hormonetherapy in breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Estrogen Antagonists
Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017