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

This study has been completed.
Sponsor:
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01016665
First received: November 17, 2009
Last updated: November 18, 2009
Last verified: November 2009
History of Changes
  Purpose

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:

U.S. FDA Resources

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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Expression of Ki-67 [ Time Frame: end of the study (june 2008) ] [ Designated as safety issue: No ]

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
Placebo
 Drug: Anastrozole
Tamoxifen 20mg and anastrozole 1 mg
Tamoxifen
Tamoxifen 20 mg day 26 days
 Drug: Anastrozole
Tamoxifen 20mg and anastrozole 1 mg
Anastrozole
Anastrozole 1mg 26 days
 Drug: Anastrozole
Tamoxifen 20mg and anastrozole 1 mg

  Eligibility

Ages Eligible for Study:   40 Years to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01016665

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

Publications:

Responsible Party: Andre Mattar MD, Federal University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01016665     History of Changes
Other Study ID Numbers: 0904/04
Study First Received: November 17, 2009
Last Updated: November 18, 2009
Health Authority: Brazil: Ethics Committee

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Hormones
Progesterone
Tamoxifen
Anastrozole
Aromatase Inhibitors
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
 Pharmacologic Actions
Progestins
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Bone Density Conservation Agents
Estrogen Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013